Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
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
Assistance Publique - Hôpitaux de Paris
652 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria11
- 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 Criteria20
- 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
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Interventions
hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg morning, noon and evening) vaginally from the evening of the puncture until the pregnancy test result
Triptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg /day (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test
Locations(1)
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NCT06150703