NCT03507673 Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase in Assisted Reproduction
| NCT ID | NCT03507673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Luebeck |
| Condition | Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2018-05-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2018-05-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 to evaluate the time point of the luteoplacental shift in patients achieving pregnancy after transfer of cryopreserved embryos subsequently to IVF/ICSI cycles. Secondary objectives are to study the characteristics of the placental progesterone increase and its function as a predictor of the course and development of pregnancies and to study vaginal/endometrial microbiota at baseline and changes associated with shift into luteal phase and early pregnancy and how this potentially relates to pregnancy outcome. Study Design: Prospective, multi-center, observational clinical cohort study. For the primary objective, data from a single center will be also be retrospectively analyzed. Study population: Female patients aged 18 to 45 years undergoing transfer of embryos after freezing and thawing 2PN oocytes or embryos. Interventions: Blood withdrawal, vaginal/endometrial swabs and endocrine and microbiom analyses. Study parameters/endpoints: The main parameter is time point of progesterone increase in pregnancy in relation to initial progesterone levels by pregnancy status. Secondary, slope and magnitude of placental progesterone increase and its relevance as a predictor for the course and development of pregnancies/babies. Furthermore, vaginal microbiota of women undergoing embryo transfer and of women in early pregnancy are parameter of this study.
Eligibility 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)
Contact & Investigator
Georg Griesinger, MD
PRINCIPAL INVESTIGATOR
Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
Frequently Asked Questions
Who can join the NCT03507673 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03507673 currently recruiting?
Yes, NCT03507673 is actively recruiting participants. Contact the research team at georg.griesinger@uni-luebeck.de for enrollment information.
Where is the NCT03507673 trial being conducted?
This trial is being conducted at Saarbrücken, Germany, Lübeck, Germany, Düsseldorf, Germany, Kiel, Germany and 1 additional location.
Who is sponsoring the NCT03507673 clinical trial?
NCT03507673 is sponsored by University of Luebeck. The principal investigator is Georg Griesinger, MD at Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin. The trial plans to enroll 1,200 participants.