💬In plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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