Status:
RECRUITING
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
In Vitro Fertilization
ICSI Intracytoplasmic Spermatozoid Injection
Eligibility:
FEMALE
18-39 years
Phase:
PHASE3
Brief 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...
Detailed Description
It is currently established that obtaining a large number of oocytes is a key of success in IVF/ICSI cycles. However, it is also a risk factor for ovarian hyperstimulation syndrome (OHSS) and a risk f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 27 2027
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT06150703
Start Date
June 27 2024
End Date
September 27 2027
Last Update
August 24 2025
Active Locations (1)
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1
Maeliss Peigné
Bondy, France