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

NCT07613528 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Montpellier

Phase

Phase 3

Started

2027-03

Last updated

2026-06-02

Condition(s) studied

PregnancyProgesterone SupplementationLow Serum Progesterone

Investigational drug(s) / intervention(s)

Progesterone Injectable →PlaceboProgesterone Vaginal Suppository →

Progesterone Injectable: 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: 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: 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 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

37 Years

Healthy volunteers

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 determined by a previous study; * Subjects participating in another interventional research.

Primary outcome measure(s)

Live birth rate — At postpartum follow-up (Visit 4: Month 9 ±1 month)
Defined as a birth of at least one live born baby, weighing 500 g or more or 20 weeks or more of gestation, with the birth of twins counted as one live birth.

Trial sites (1)

Facility	City	Region	Status
CHU de Montpellier	Montpellier	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07613528 on ClinicalTrials.gov ↗ ← All trials in France