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

NCT07613528 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Progesterone Supplementation
  • Low Serum Progesterone

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.

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    collaborator INDUSTRY

  • Hospices Civils de Lyon

    collaborator OTHER

  • Direction Générale de l'Offre de Soins

    collaborator OTHER_GOV

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Noémie RANISAVLJEVIC, MD, PhD · University Hospital, Montpellier

  • Tal ANAHORY, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-31
Primary Completion
2029-09-30
Completion
2030-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613528 on ClinicalTrials.gov