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

RecruitingPhase 3Ages 18 Years - 39 YearsFemaleAssistance Publique - Hôpitaux de Paris
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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
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What it tests

  • Ovulation induction with hCG + Luteal phase support with vaginal progesterone
  • Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin
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Where

1 site
Maeliss Peigné
Bondy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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