Investigating the role of hormones and microbiome in pregnancy during assisted reproduction
Official title: Prospective, Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase and Pregnancy After Embryo Transfer in Assisted Reproduction
Run by University of Luebeck · NCT03507673 · Data updated 2026-11-12
This study is trying to see how hormone levels and the bacteria in the vagina and uterus affect early pregnancy in women undergoing assisted reproduction with frozen embryos.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 1200 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 5 sites (Saarbrücken, Saarland and 4 other locations) |
| Status | Recruiting |
| Started | May 2, 2018 |
| Main results expected | August 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | May 22, 2025 |
| Trial ID | NCT03507673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 45 who are undergoing the transfer of cryopreserved embryos.
✕Probably not a fit
Patients undergoing fresh IVF/ICSI embryo transfers or those with uterine malformations or endometrial abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between progesterone levels and the vaginal/endometrial microbiome during the luteal phase in patients undergoing assisted reproduction. It focuses on determining the timing of the luteoplacental shift, which is crucial for maintaining early pregnancy. Blood samples and microbiological swabs will be collected from participants who are transferring cryopreserved embryos to assess these associations. The study seeks to fill gaps in understanding how hormonal and microbiological factors may influence pregnancy outcomes.
Why it matters
Potential benefit: If successful, this study could enhance understanding of factors affecting pregnancy maintenance, potentially leading to improved fertility treatments.
How similar studies have gone: While some studies have explored aspects of the microbiome in relation to fertility, this specific investigation into the interplay between progesterone and the microbiome during the luteal phase is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 45 years 2. Transfer of cryopreserved embryos Exclusion Criteria: 1. Fresh IVF/ICSI embryo transfer cycle 2. Evidence for ovulation on ultrasound previous to embryo transfer confirmed by a follicle ≥14mm or by a progesterone ≥1.0 µg/l in programmed cycles 3. Uterus malformations, endometrial abnormalities (on ultrasound or diagnosed by previous hysteroscopy)
Where it's running
-
Ivf-Saar
Saarbrücken, Saarland, Germany Recruiting -
Universitäres Kinderwunschzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting -
Universitätsklinikum Düsseldorf,UniKiD
Düsseldorf, Germany Recruiting -
Universitäres Kinderwunschzentrum
Kiel, Germany Recruiting -
University of Luebeck
Lübeck, Germany Recruiting
Study contacts
- Principal investigator: Georg Griesinger, MD — Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
- Study coordinator: Georg Griesinger, MD
- Email: georg.griesinger@uni-luebeck.de
- Phone: +49451 50577810
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.