Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles

Recruiting now · Phase 3

Conditions studied: In Vitro Fertilization, ICSI Intracytoplasmic Spermatozoid Injection

In brief

The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).

Key facts

Study ID

NCT06150703

Run by

Assistance Publique - Hôpitaux de Paris

People needed

652

Starts

2024-06-27

Expected to finish

2027-09-27

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Maeliss Peigné — Bondy, France (enrolling)

Full record on ClinicalTrials.gov

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