Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07613528 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Individualized Prolonged Luteal Support After Fresh Embryo Transfer in Women With Low Progesterone

Study acronym: ProLIS
StatusNot Yet Recruiting
PhasePhase 3
Started2027-03
View on ClinicalTrials.gov ↗

Amendment history

2026-05-29
minor
Study Status, Study Description, Arms and Interventions, Eligibility v1
Eligibility criteria+68 characters
[...] nized vaginal progesterone; With a positive pregnancy test (bhCGβ-hCG > 100 UI/L); With a serum progesterone level below 17 ng/mL [...] ment stimulating endogenous progesterone secretion (such as Gonadotropin-Releasing Hormone: GnRH agonist, or chorionique gonadotropic hormone: hCG injections); Patients with intolerance or contraindicat [...]
Study description+89 characters
Introduction: Progesterone is essential for implantation and early pregnancy maintenance. After ovarian stimulation for In vitro fertilization (IVF), luteal phase insufficiency may occur, requiring luteal pha [...] trial. Women aged 18-37 years with positive pregnancy test (Bêta chorionique gonadotropic hormone: β-hCG >100 IU/L) and serum progesterone <17 ng/mL after fres [...] total of 214 participants will be enrolled across multiple In vitro fertilization (IVF) centers.
2026-05-21
minor
Original filing
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.
Trial Details
NCT Number NCT07613528
Lead Sponsor University Hospital, Montpellier
Collaborators: IBSA Institut Biochimique SA, Hospices Civils de Lyon, Direction Générale de l'Offre de Soins
Conditions Pregnancy, Progesterone Supplementation, Low Serum Progesterone
Enrollment 214 participants
Start Date 2027-03
Primary Completion 2029-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-02