CompletedNot Applicable

Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy

France168 participantsStarted 2019-11-01

Plain-language summary

Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy. There are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer. However, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum. Then, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered. The main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.

Who can participate

Age range

18 Years – 43 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * women between 18 and 43, * having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy, with measurement of serum progesterone on the day of transfer Exclusion Criteria: * frozen-thawed transfer of a day-2 or -3 or -6 embryo, * double embryo transfer, * other protocol than HRT, * patient without serum progesterone measurement on the day of transfer

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identification of factors on the embryo transfer day that predict live birth after frozen-thawed embryo transfer

Timeframe: On the day of embryo transfer (Day 0)

Trial details

NCT IDNCT05588635

SponsorCentre Hospitalier Régional Metz-Thionville

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Ovarian Hyperstimulation Syndrome trials