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NOT YET RECRUITING
NCT07613528
PHASE3

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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 (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.

Official title: Interest of Individualized Prolongation of Subcutaneous Luteal Phase Support up to 8 Weeks for Patients Pregnant After a Fresh Embryo Transfer and With Low Serum Progesterone Level at Pregnancy Test - a Multicentric Randomized Double Blinded Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 37 Years

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2027-03

Completion Date

2030-09

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Progesterone Injectable

One injection of PROGIRON® (25 mg pre-filled syringe) per day will be administered until 8 weeks of gestation (D1 to D42).

DRUG

Placebo

One injection of PLACEBO (identical in appearance to the PROGIRON® pre-filled syringe) per day will be administered until 8 weeks of gestation (D1 to D42).

DRUG

Progesterone Vaginal Suppository

Vaginal progesterone treatment with PROGESTAN® (200 mg 3 times daily) will be continued for 4 days after initiation of the investigational medicinal product (D1 to D4), pending achievement of stable progesterone serum concentrations with injectable progesterone.

Locations (1)

CHU de Montpellier

Montpellier, France