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Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase in Assisted Reproduction

Recruitingn/aAges 18 Years - 45 YearsFemaleUniversity of Luebeck
NCT03507673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: The hormone progesterone has different functions. In pregnancy, it is vital for maintenance thereof. In early pregnancy, progesterone is synthesized by the Corpus luteum (CL). Its production shifts from the CL to the placenta after several gestational weeks. This process is termed luteoplacental shift. Still, the exact time point of the luteoplacental shift remains unknown. Furthermore, the characteristics of placental progesterone increase and its relevance for the course of pregnancy has not been studied so far. Furthermore, recent studies have shown an influence of abnormal vaginal microbiota on the likelihood to achieve and maintain pregnancy. Little is known about possible crosslinks between endocrinology and vaginal/endometrial microbiota which is why this study aims to investigate possible associations of such kind. Objective: The primary objective of this study is

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📋 Eligibility rules (as published)
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)
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What it tests

  • Blood samples and microbiological swaps
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Where

5 sites
IVF-SAAR
Saarbrücken, Germany
Universitäres Kinderwunschzentrum Lübeck
Lübeck, Germany
Universitätsklinikum Düsseldorf,UniKiD
Düsseldorf, Germany
Universitäres Kinderwunschzentrum
Kiel, Germany
University of Luebeck
Lübeck, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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