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RECRUITING

NCT06150703

PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

652

Start Date

2024-06-27

Completion Date

2027-09-27

Last Updated

2025-08-24

Healthy Volunteers

Conditions

In Vitro Fertilization ICSI Intracytoplasmic Spermatozoid Injection

Interventions

DRUG

Ovulation induction with hCG + Luteal phase support with vaginal progesterone

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

DRUG

Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin

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

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

Locations (1)

Maeliss Peigné

Bondy, France