Actively Recruiting
Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-24
652
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates luteal phase support strategies in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles. Researchers aim to address the paradox where obtaining a large number of oocytes improves success but increases risks like ovarian hyperstimulation syndrome (OHSS) and implantation failure due to altered endometrial receptivity. The study evaluates a new protocol combining GnRH agonist triggering with GnRH agonist luteal phase support compared to the standard approach using hCG triggering and vaginal progesterone support. Two treatment groups are compared: one receiving hCG injection before oocyte retrieval and vaginal progesterone afterward, and the other receiving a GnRH agonist (Triptorelin) injection before retrieval with nasal GnRH agonist (Nafarelin) support during the luteal phase. Both protocols begin treatment 36 to 38 hours before oocyte retrieval and continue luteal support until the first pregnancy test. The new protocol is designed to reduce OHSS risk and improve pregnancy rates by supporting the body's own hormone production. Participants will be closely monitored through pregnancy testing and ultrasound assessments to measure outcomes such as live birth rates, embryo implantation, clinical pregnancy, miscarriage, and pregnancy complications. Hormone levels will be tracked at oocyte retrieval and during follow-up lasting up to 19 months. Safety events including OHSS and adverse outcomes will also be recorded. Women aged 18 to 39 undergoing their first or second IVF/ICSI attempt are involved, with the study lasting through pregnancy and delivery outcomes.
CONDITIONS
Brief Title
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 39 years
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from partner or donor under French law
- First or second attempt at IVF or ICSI for pregnancy
- Body mass index (BMI) less than 35 kg/m2
- Anti-Mullerian hormone (AMH) greater than 1 ng/ml and/or antral follicle count of 8 or more within the past year
- AMH less than 5 ng/ml and/or antral follicle count less than 40 within the past year
- Treatment with recombinant FSH
- Use of antagonist protocol with or without pre-treatment
- Initial dose of recombinant FSH between 75 and 450 IU
- Signed informed consent
- Affiliation to the social security system (excluding AME)
You will not qualify if you...
- Diagnosed with HIV infection
- ICSI with sperm from testicular biopsy
- Undergoing pre-implantation diagnosis
- Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH less than 1.2 IU/L)
- History of severe ovarian hyperstimulation syndrome (OHSS)
- Unoperated hydrosalpinx
- Intracavitary polyps or myomas deforming the uterine cavity
- Known hypersensitivity to study drugs or excipients
- Gynecological bleeding or genital hemorrhage
- History of epilepsy or intracranial tumors causing epilepsy
- Tumors of hypothalamus or pituitary gland
- Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
- Severe adenomyosis requiring long protocol
- Carcinoma of ovary, uterus, or breast
- Active thromboembolic events
- Severe liver function impairment
- Breastfeeding women
- Under court protection, guardianship, or curatorship
- Currently participating in another therapeutic interventional trial
- Unable to speak or understand French
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From ovulation triggering until the first pregnancy test (approximately 14 days after oocyte retrieval)
Participants receive ovulation triggering either with hCG or Triptorelin, followed by luteal phase support with vaginal progesterone or nasal Nafarelin until the pregnancy test.
1 visit for ovulation triggering and oocyte retrieval, followed by daily medication until pregnancy test
Duration - Up to 19 months
Participants are monitored for pregnancy outcomes and adverse events up to delivery.
Periodic visits for pregnancy monitoring and safety assessments
Trial Site Locations
Total: 1 location
1
Maeliss Peigné
Bondy, France
Actively Recruiting
Research Team
M
Maeliss Peigné, MCU-PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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