GnRH agonist for luteal support after GnRH agonist ovulation trigger in IVF/ICSI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares the standard hCG trigger plus vaginal progesterone luteal support with an alternative strategy using a GnRH agonist trigger (triptorelin) followed by continued GnRH agonist luteal support (nafarelin). Participants are people aged 18–39 undergoing their first or second IVF/ICSI cycle with antagonist protocols, recombinant FSH, BMI <35 and ovarian reserve within specified AMH/AFC ranges. Outcomes include clinical pregnancy, live birth, and the incidence of ovarian hyperstimulation syndrome (OHSS) after fresh embryo transfer. The approach aims to preserve endogenous luteal function via maintained LH activity while reducing the OHSS risk linked to hCG-triggered cycles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
* Patients aged 18 to 39 included
* First or second attempt at IVF or ICSI for pregnancy
* BMI \< 35 kg/m2
* Anti-Mullerian hormone (AMH) \> 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
* AMH \< 5 ng/ml and/or antral follicle count \<40 within the year prior to inclusion
* Treatment with recombinant FSH
* Antagonist protocol (with pre-treatment or not)
* Initial dose of recombinant FSH between 75 and 450 IU
* Signed informed consent
* Affiliation to the social security system (excluding AME)

Exclusion Criteria:

* Patient diagnosed with HIV infection
* ICSI with sperm from testicular biopsy
* Pre-implantation diagnosis
* Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH \<1.2 IU/L)
* History of severe ovarian hyperstimulation syndrome (OHSS)
* Unoperated hydrosalpinx
* Intracavitary polyps or myomas deforming the cavity
* Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, Sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid).
* Gynaecological bleeding or genital haemorrhage
* History of epilepsy and/or intracranial tumors potentially causing epilepsy
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
* Severe adenomyosis requiring a long protocol
* Carcinoma of the ovary, uterus or breast
* Active thromboembolic events
* Severe impairment of liver function
* Breastfeeding women
* Patients under court protection, guardianship or curators
* Current participation in another therapeutic interventional trial on the day of inclusion
* Patients who do not speak or understand French

Where it's running

• Maeliss Peigné
  Bondy, France Recruiting

Study contacts

• Study coordinator: Maeliss Peigné, MCU-PH
• Email: maeliss.peigne@aphp.fr
• Phone: 01 48 02 68 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.