Tuberculosis (TB) is a common cause of infertility in humans, especially in regions with high TB prevalence. However, the impact of latent TB infection (LTBI) on pregnancy outcomes following assisted reproduction in patients with infertility remains unclear. This systematic review and meta-analysis aimed to assess significant differences in pregnancy outcomes after assisted reproduction between infertile patients with and without LTBI.

Systematic review and meta-analysis using the Grading of Recommendation, Assessment, Development and Evaluation approach.

PubMed, Embase and Web of Science were searched from inception to 1 September 2025.

Case–control or cohort studies comparing assisted reproduction outcomes between infertile patients with and without LTBI, diagnosed via tuberculin skin test or interferon-gamma release assay, were included. Outcomes of interest were clinical pregnancy rate, miscarriage rate and live birth rate.

Two independent reviewers used standardised methods to search, screen and code included studies, extracted data and assessed study quality using the Newcastle-Ottawa Scale. Meta-analysis was performed using a fixed-effects model. Heterogeneity was evaluated with the I² statistic. Sensitivity analysis was performed using the leave-one-out method, and publication bias was assessed using funnel plots and Egger’s test.

Four studies met the inclusion criteria for this meta-analysis. The included studies showed low heterogeneity for clinical pregnancy rate (I²=45.9%), miscarriage rate (I²=0%) and live birth rate (I²=8.9%). The miscarriage rate was significantly higher in the LTBI group than in the non-LTBI group (OR 1.14; 95% CI 1.00 to 1.31; p=0.049). No significant differences were observed between the two groups in terms of clinical pregnancy rate (OR 0.98; 95% CI 0.91 to 1.06; p=0.692) and live birth rate (OR 0.96; 95% CI 0.88 to 1.04; p=0.305). Sensitivity analysis confirmed the robustness of the miscarriage rate outcome. Publication bias was low for clinical pregnancy and miscarriage rates but potential bias was detected for live birth rate (Egger’s test p=0.029). The overall certainty of evidence was rated as low due to the observational nature of included studies and limited number of studies.

Infertile patients with LTBI might have a higher miscarriage rate after assisted reproduction compared with non-LTBI patients, although no differences were observed in clinical pregnancy or live birth rates. These results, particularly regarding miscarriage, should be interpreted with caution due to the limitations of the available evidence. Further high-quality studies are needed to strengthen the evidence base.

CRD42024605623.

EmbryoGlue, a commercially available hyaluronic acid (HA)-enhanced culture medium, is commonly recommended as an adjunct to support embryo implantation. Given the current lack of conclusive evidence regarding its efficacy and safety, this study aims to evaluate the effectiveness and safety of HA-enriched medium in women undergoing in vitro fertilisation (IVF) treatment.

This multicentre, patient-blinded, randomised controlled trial involves couples planning a single fresh or frozen blastocyst-stage embryo transfer. On the morning of embryo transfer, individual blastocysts are randomly allocated to either a high-concentration HA medium (EmbryoGlue, 0.5 mg/mL) or a conventional low-concentration HA medium (G-2 PLUS, 0.125 mg/mL). The primary outcome is live birth rate per embryo transfer, with secondary outcomes including biochemical pregnancy rate, clinical pregnancy rate, miscarriage rate, ectopic pregnancy rate, ongoing pregnancy rate, multiple pregnancy rate, as well as obstetric and perinatal outcomes and related complications. The trial plans to enrol 858 female patients from four IVF centres in China, with 429 patients in each group.

The study has been approved by the Ethics Committee of Northwest Women’s and Children’s Hospital (approval no.: 2024–127), and all participating centres have obtained approvals from their respective institutional review boards or ethics committees. Results will be disseminated through publication in a peer-reviewed open-access journal and oral presentations at relevant domestic and international academic conferences.

NCT06492785.

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

Teenage pregnancy is a significant global public health challenge with far-reaching consequences for young mothers, their children, families and society at large. Yet, the evidence synthesis landscape in teenage pregnancy prevention remains fragmented, with systematic reviews typically examining specific intervention types, target populations or geographical settings in isolation. This protocol outlines a scoping review to map and describe the extent, range and nature of existing systematic review evidence on interventions aimed at addressing teenage pregnancy.

We will conduct a comprehensive search of multiple databases, including PubMed Central, Embase, CINAHL and ProQuest Central, systematic review repositories and grey literature sources from inception to date. Two reviewers will independently screen titles, abstracts and full-text articles using predetermined inclusion and exclusion criteria, with disagreements resolved through discussion or third-party adjudication. Data will be extracted using a standardised form and synthesised narratively, with results presented descriptively, as no meta-analysis is planned for this scoping review.

This review does not require ethical approval, as only published data will be analysed. Results will be shared using peer-reviewed publications. Data sets emerging from the study will be made available on the Open Science Framework.

This review was initially registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/F2AH7) in July 2025. The protocol will be updated and re-registered after incorporating feedback from the journal’s peer review process.

Surrogacy has become a vital reproductive option for individuals and couples who are unable to conceive naturally. This study explores the experiences of surrogate mothers in Ghana, focusing on recruitment pathways, eligibility criteria, societal stigma and postnatal care experiences.

Qualitative phenomenological research design was used, and data were collected through semi-structured interviews and analysed using thematic content analysis.

Three private agencies that source surrogate mothers for assisted reproduction facilities in Accra, Ghana. Data were collected between December 2020 and June 2021.

Twenty-one surrogate mothers aged 20–40 years who were either pregnant (gestational age ≥16 weeks) or had delivered within the past 2 years were recruited from three private agencies in Accra.

Thematic analysis generated four themes: (1) recruitment pathways into surrogacy, (2) eligibility criteria and assessments, (3) experiences of stigma and concealment and (4) postnatal care and recovery. These themes illustrate how surrogate mothers in Ghana navigate recruitment processes, psychosocial and medical evaluations, societal stigma and challenges with discharge and follow-up care.

These findings underscore the need for systemic changes, including enhanced postnatal care, structured psychological evaluations and culturally sensitive interventions to reduce stigma.

Male infertility can be primary or secondary, depending on whether pregnancy has been achieved before or not, but thyroid gland involvement is rarely investigated in the laboratory work-up. This study aimed to assess thyroid hormone abnormalities among primary and secondary infertile men.

This is a cross-sectional study involving male partners of infertile couples presenting at the fertility clinic with an established diagnosis of infertility after review by the clinician. Males with proven fertility served as controls.

The study was conducted at the Human Reproduction and Research Programme unit and the Chemical Pathology Laboratory of the University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.

This study involved 200 participants who consisted of 50 controls (fertile men) and 150 infertile men (80 primary infertile men and 70 secondary infertile men). The participants were reviewed by a clinician, and a semen analysis was done to ascertain their fertility status.

The results show that sperm indices, such as sperm count, total motility, progressive motility, viable sperm cells, normal forms and volume were significantly lower (p

Thyroid abnormalities were more predominant among secondary infertile men than primary infertile men in this study.

Infertility is a significant reproductive health issue that affects couples physically, emotionally and socially. This qualitative study aims to explore the psycho-social experiences and coping strategies of infertile couples attending infertility clinics at Saint Paul’s Hospital, Addis Ababa, Ethiopia.

This study employed a descriptive phenomenological research design. In-depth interviews were conducted with 12 purposively selected couples experiencing infertility. The study used thematic analysis to capture the emotional, social and psychological impacts of infertility on individuals and their relationships.

Key themes identified include emotional distress, social stigma, marital strain and a sense of isolation. Participants reported experiencing feelings of shame, depression and anxiety, often exacerbated by societal expectations and pressure to conceive. Coping strategies varied across individuals and included seeking medical intervention, social support, religious faith and, in some cases, withdrawal from social interactions.

The study highlights the need for comprehensive psychological support and counselling services in infertility care to address the mental health and social challenges faced by infertile couples. Promoting awareness to reduce stigma and enhancing social support systems may improve the overall well-being of affected individuals.

The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

NCT06334003

The COVID-19 pandemic disrupted maternal healthcare access globally, leading many women to give birth outside of healthcare facilities, often assisted by traditional birth attendants (TBAs). This study explored the experiences of Kenyan women who gave birth outside of healthcare facilities during the COVID-19 pandemic based on the Person-Centered Maternity Care (PCMC) framework.

This study used data from descriptive qualitative indepth interviews with Kenyan women who gave birth outside of healthcare facilities between March and November 2020. Participants lived within the catchment areas of six health facilities in Kiambu and Nairobi counties and were recruited by community leaders and community health workers. Interviews were conducted in 2020 via phone and inductively coded and analysed by a team of researchers.

A total of 28 Kenyan women who gave birth outside of healthcare facilities between March and November 2020 completed indepth interviews.

In this sample, approximately one-third of women were assisted by TBAs, while the majority were supported by friends and family members. Women generally described salient aspects of their care pertaining to the PCMC domain of supportive care. During labour, birth and the immediate postpartum, women received emotional support, basic medical assistance and instrumental support such as preparing food and baths. However, women also described concerns about giving birth outside of healthcare facilities, including poor hygiene and lack of privacy in birthing spaces as well as instances of verbal and physical harassment by TBAs. Overall, women worried about potential complications during birth, and many women delayed seeking postpartum and postnatal care.

Women who were unable to access healthcare facilities during the COVID-19 pandemic relied on TBAs and/or friends and family for support during labour and birth. These women faced gaps in PCMC, specifically related to supportive care. Given that birthing outside of healthcare facilities remains common globally, particularly during emergencies such as pandemics, TBAs should be supported to provide more person-centred care to women giving birth outside of healthcare facilities.

Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Dysmenorrhoea (period pain) is a global public health issue affecting up to 91% of the 1.8 billion individuals who menstruate. While research has emphasised the improvement of menstrual health in low-middle-income countries, undertreated dysmenorrhoea remains an issue in high-income countries (HICs), where individuals often assume their pain experiences are normal. Studies report that individuals with dysmenorrhoea delay seeking medical care, avoid it entirely or are subjected to diagnostic and treatment delays. Difficulties accessing care are troubling, as individuals may suffer without access to evidence-based techniques, as well as the potential for underlying pathologies (eg, endometriosis, pelvic inflammatory disease) to go undiagnosed.

Many HICs have launched strategies for women’s health to address gaps in care access and knowledge around menstruation. Guided by Levesque and colleagues' (2013) Conceptual Framework of Access to Healthcare, this review will contribute to these strategies by providing an overview of factors affecting healthcare access for dysmenorrhoea in HICs from the point of perceiving a healthcare need to engaging with care, as well as factors affecting perceived quality of care.

This scoping review will follow the Joanna Briggs Institute’s (JBI) guidance for scoping reviews and will be conducted with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist extension for Scoping Reviews. Guided by Levesque and colleagues’ (2013) Conceptual Framework of Access to Healthcare, searching will seek to locate both peer-reviewed studies across PubMed, CINAHL, PsycINFO and Web of Science databases, as well as using web scraping to locate relevant grey literature. Results will be synthesised and mapped to construct a pathway to care, highlighting factors affecting the healthcare access for dysmenorrhoea, as well as factors related to the quality of healthcare interactions.

This review does not require ethical approval, as only existing data will be analysed. Results will be shared using peer-reviewed publications and conference presentations. Datasets emerging from the study will be made available on Open Science Framework.

This review was initially registered on Open Science Framework (https://osf.io/2dsrc/) in February 2024, with an updated protocol registered in February 2025.

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

CRD42024564332.

Childhood cancer treatment can cause subfertility in adulthood. Ovarian or testicular tissue preservation is a rapidly evolving field with significant potential benefits. However, the establishment of patient-centred reproductive survivorship pathways remains a challenge in clinical settings due to a lack of robust evidence to inform its development. Patient and public involvement and engagement (PPIE) consultation may help ensure that future studies align with patient needs and that tailored survivorship care pathways are developed for young people with preserved fertility tissue.

This PPIE consultation aimed to identify priority areas for future research that would support the development of a tailored survivorship care pathway for childhood cancer survivors who have preserved tissue for future fertility.

Recruitment occurred through national networks, including collaborations with advocacy groups such as Candlelighters and clinical networks. Data were collected via telephone or online unstructured interviews, with some supplementary email exchanges. Thematic analysis was used to identify emergent themes. The Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 guidelines were used to help guide PPIE.

An online focus group and/or a one-to-one interview with e-mail interactions.

In total, 12 unique participants took part in a focus group and/or interview. Participants included parents of children who had stored tissue, young adult cancer survivors with stored tissue and five clinicians from the leading National Health Service (NHS) centres in the UK.

Six key themes emerged that highlighted unmet needs and priority areas for research: (1) Lack of communication and information; (2) unmet needs in follow-up care; (3) emotional impact and psychological support; (4) importance of patient and parental involvement; (5) desire for information and education; and (6) long-term concerns and support. Parents, young adults and healthcare clinicians found talking about fertility issues difficult. They noted that consistency of care, education resources and access to emotional support were important areas where improvements could be made. We used thematic analysis to help identify patterns in the data, and we used the Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 reporting guidelines for PPIE work.

PPIE provided valuable insights into the experiences of childhood cancer survivors with preserved fertility tissue, their parents and clinicians, highlighting priority areas to guide future research and ensure it addresses the concerns of care recipients. Our findings suggest that childhood cancer survivors who preserve tissue for future fertility need personalised follow-up care with information and psychological support. A larger sample of participants, studied using a qualitative research design, is needed to capture the full range of experiences, needs and preferences and to ensure that care is inclusive and relevant to the wider population.

Tuberculosis (TB) is a significant factor contributing to infertility. For some infertile patients, chest radiography (CXR) screenings prior to assisted reproductive treatment (ART) reveal old/inactive TB lesions. However, the pregnancy outcomes after ART for such patients who had a history of prior anti-TB treatment remain unclear.

Retrospective cohort study.

Peking University Third Hospital, a tertiary care centre.

This study analysed and focused on infertile patients aged 20–50 years with prior TB lesions on CXR (treated/untreated) and normal CXR. Active TB cases were excluded from this study. Patients were categorised into three groups based on CXR findings and prior anti-TB treatment: treated prior-pulmonary TB (PTB) group, untreated prior-PTB group and a non-PTB control group with normal CXR.

ART outcomes, including clinical pregnancy rate, miscarriage rate and live birth rate, were compared among the groups.

Among 8769 patients analysed, including treated prior-PTB group (n=171), untreated prior-PTB group (n=791) and non-PTB group (n=7807). The treated prior-PTB group showed a similar clinical pregnancy rate (41.5% vs 38.1%, p=0.360) and live birth rate (35.3% vs 30.6%, p=0.187) compared with the non-PTB group. The miscarriage rate was slightly lower in the treated prior-PTB group than in the non-PTB group (11.3% vs 15.5%, p=0.325), although the discrepancy was not statistically significant. Compared with the untreated prior-PTB group, the treated prior-PTB group exhibited significantly higher live birth rate (35.3% vs 23.8%, p

Anti-TB treatment in infertile women with prior PTB lesions was associated with improved ART outcomes, comparable to those in patients without TB lesions. This suggests a potential clinical benefit of anti-TB treatment in improving reproductive outcomes in this population. Further research is warranted to explore ART outcomes in patients with untreated prior TB lesions.

The quality of the blastocyst (day 5/6 embryo) selected for transfer is critical for the success of in vitro fertilisation (IVF) treatment. Embryologists perform blastocyst evaluation by observing the morphology of each blastocyst. Human assessment is subjective and inconsistent in predicting which blastocyst can result in a successful pregnancy or birth. Several artificial intelligence (AI) methods have been proposed to predict IVF outcomes from blastocyst images. However, the reasoning processes of these AI methods are uninterpretable, causing epistemic and ethical concerns that prevent their implementation in clinical practice. To address this issue, the authors developed a novel interpretable AI method for blastocyst selection. The method is clinically applicable because it is transparent to embryologists and allows them to understand its reasoning processes. This randomised controlled trial (RCT) aims to test the effectiveness of this blastocyst selection method with the aim of improving IVF outcomes.

In this single-centre, single-blind RCT, we will enrol 1100 women aged 20–35 years undergoing their first cycle of IVF, with or without intracytoplasmic sperm injection. The study will be conducted at Nanjing Drum Tower Hospital, a public class A tertiary hospital in China. On the fifth day of embryo culture, participants with two or more usable blastocysts will be randomised in a 1:1 ratio to either the conventional morphology group or the AI group. The primary outcome is ongoing pregnancy, defined as a viable intrauterine pregnancy of 12 weeks gestation or more.

The research ethics committee of the Nanjing Drum Tower Hospital approved this study (approval number: 2023-259-02). All participants will provide written informed consent prior to enrolment. The findings will be presented at international conferences and published in peer-reviewed journals.

ChiCTR2300076851.

Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that affects reproductive-age women, impairing their ability to conceive and sustain fertility. The efficacy of conventional therapies varies among individuals and is often accompanied by multiple side effects. Acupuncture has shown potential in fertility management for PCOS patients. However, the current evidence on its impact on pregnancy outcomes remains inconclusive. This study aims to synthesise the latest evidence regarding the efficacy and safety of acupuncture in infertile women with PCOS.

A comprehensive literature review will be conducted by searching for randomised controlled trials of acupuncture for infertile women with PCOS in English and Chinese language databases, including the Cochrane Database of Clinical Trials, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed. The primary outcome will be live birth rat (LBR) and clinical pregnancy rate (CRP). The secondary outcomes will include multiple pregnancy rate (MPR), ongoing pregnancy rate (OPR), miscarriage rate (MR), ovulation rate (OR), hyperstimulation ovarian syndrome (OHSS) and adverse events. The risk of bias will be assessed using the Cochrane Risk of Bias 2.0 tool. Meta-analysis will be conducted to synthesise the evidence for each outcome, if possible. The heterogeneity will be statistically assessed using a ² test and I² statistic. Subgroup analyses, sensitivity analyses and publication bias will be performed if the available data are sufficient. Evidence strength will be graded using the Grading of Recommendations Assessment, Development and Evaluation system. This protocol is developed following the guidelines of PRISMA-P 2015.

Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal.

CRD42024601226.

Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

CCMO NL81210.068.22, registered 25 September 2023.