GnRH agonist for luteal support after GnRH agonist ovulation trigger in IVF/ICSI
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
This tests whether using a GnRH agonist to trigger ovulation and continuing a GnRH agonist for luteal support improves pregnancy outcomes and reduces OHSS for people undergoing IVF or ICSI.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 652 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bondy) |
| Trial ID | NCT06150703 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people 18–39 having their first or second IVF/ICSI with antagonist protocols, BMI under 35, AMH between 1 and 5 ng/ml (or AFC 8–40), treated with recombinant FSH, and covered by French social security.
Not a fit: Patients with hypogonadotropic hypogonadism, prior severe OHSS, those using testicular biopsy sperm for ICSI, or those undergoing preimplantation genetic diagnosis are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could increase the chance of pregnancy from fresh transfer while lowering the risk of OHSS.
How similar studies have performed: Previous studies have shown GnRH agonist triggering reduces OHSS risk and preliminary reports suggest continuing GnRHa in the luteal phase may support implantation, but the combined approach has limited phase 3 evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bondy
- Maeliss Peigné — Bondy, France (Recruiting)
Study contacts
- Study coordinator: Maeliss Peigné, MCU-PH
- Email: maeliss.peigne@aphp.fr
- Phone: 01 48 02 68 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.