Individualized Prolonged Luteal Support After Fresh Embryo Transfer in Women With Low Progesterone (NCT07613528) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Individualized Prolonged Luteal Support After Fresh Embryo Transfer in Women With Low Progesterone
France214 participantsStarted 2027-03
Plain-language summary
The goal of this clinical trial is to compare live birth rate in a control group versus an interventional group in subjects aged 18 to 37, pregnant after a fresh embryo transfer and with a serum progesterone level below 17 ng/mL on the day of pregnancy test while using vaginal progesterone as a luteal support. .
This is the first randomized controlled trial to assess the benefit of prolonged subcutaneous progesterone administration in patients with a positive pregnancy test (Bêta chorionique gonadotropic hormone: β-hCG \>100 IU/L) after fresh transfer and low progesterone level (\<17 ng/mL).
Half the participants will be offered a an extension of luteal phase support , by subcutaneous progesterone supplementation for 6 weeks, the other half will have placebo injections. A double-blind, placebo-controlled, randomized design was chosen to prevent selection bias and ensure the comparability of both study arms.
Who can participate
Age range
18 Years – 37 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:
* Patient aged 18 to 37 year-old;
* Patients with a BMI below 34 kg/m2;
* After a fresh embryo transfer following an ovarian hyperstimulation for an IVF with a luteal phase support based on micronized vaginal progesterone;
* With a positive pregnancy test (β-hCG \> 100 UI/L);
* With a serum progesterone level below 17 ng/mL on the day of pregnancy test;
* Patient able to self-administer subcutaneous progesterone injections, either alone or with the help of her partner.
Exclusion Criteria:
* Patient undertaking an additional source of progesterone (oral or injected) or a treatment stimulating endogenous progesterone secretion (such as Gonadotropin-Releasing Hormone: GnRH agonist, or chorionique gonadotropic hormone: hCG injections);
* Patients with intolerance or contraindication to subcutaneous progesterone administration;
* Patients with a known 21-hydroxylase deficiency;
* Patients with uterine pathology or untreated hydrosalpinx;
* Patients with a history of recurrent miscarriages (3 or more);
* Patient undergoing pre-implantation genetic testing;
* Patient unavailable or unwilling to participate in future visits or is unable to comply with trial protocol;
* Subjects unable to read or/and write French;
* Failure to obtain the consent;
* Subjects non-beneficiary of the French social security (Government medical aid (AME) excluded);
* Subjects placed under legal protection, under guardianship or under curatorship;
* Patient in an exclusion period deter…
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?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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
1
Live birth rate
Timeframe: At postpartum follow-up (Visit 4: Month 9 ±1 month)