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

Sponsor
University Hospital, Montpellier
Study ID
NCT07613528
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Low Serum Progesterone
  • Pregnancy
  • Progesterone Supplementation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 37 Years
Healthy Volunteers
Not accepted

Interventions

  • Progesterone Injectable — DRUG
    One injection of PROGIRON® (25 mg pre-filled syringe) per day will be administered until 8 weeks of gestation (Day 1 to Day 42).
  • Placebo — DRUG
    One injection of PLACEBO (identical in appearance to the PROGIRON® pre-filled syringe) per day will be administered until 8 weeks of gestation (Day 1 to Day 42).
  • Progesterone Vaginal Suppository — DRUG
    Vaginal progesterone treatment with PROGESTAN® (200 mg 3 times daily) will be continued for 4 days after initiation of the investigational medicinal product (Day 1 to Day 4), pending achievement of stable progesterone serum concentrations with injectable progesterone.

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
Mar 31, 2027
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control group
    Discontinuation of luteal phase support with a subcutaneous placebo daily until 8 weeks of gestation (for 6 weeks). Vaginal progesterone will be continued for 4 days after placebo initiation. Apart from these 4 days of transition treatment, the patient will not receive any additional treatment for luteal phase support (discontinuation of progesterone soft capsule administration according to the center's standard practice).
  • Experimental: Experimental group
    Prolonged luteal phase support, switched to subcutaneous progesterone 25 mg daily until 8 weeks of gestation (for 6 weeks). Vaginal progesterone will be continued for 4 days after subcutaneous progesterone initiation to ensure adequate serum levels while awaiting steady-state concentration of subcutaneous progesterone. Apart from these 4 days of transition treatment, the patient will not receive any additional treatment for luteal phase support (discontinuation of progesterone soft capsule administration according to the center's standard practice).

Primary Outcome Measure

Live birth rate [ Time Frame: At postpartum follow-up (Visit 4: Month 9 ±1 month) ]

Central Contacts

Related Studies