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

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Nafarelin; Progesterone; Triptorelin Pamoate

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 of IVF or ICSI

• BMI < 35 kg/m2

• Anti-Mullerian hormone (AMH) > 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8

• AMH < 5 ng/ml and/or antral follicle count <40

• 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 or partner with HIV, hepatitis B virus (HBV) or Hepatitis C Virus (HCV)

• 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

• 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