NCT06150703 Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
| NCT ID | NCT06150703 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | In Vitro Fertilization |
| Study Type | INTERVENTIONAL |
| Enrollment | 652 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 652 participants in total. It began in 2024-06-27 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06150703 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying In Vitro Fertilization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06150703 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 652 participants.
Is NCT06150703 currently recruiting?
Yes, NCT06150703 is actively recruiting participants. Contact the research team at maeliss.peigne@aphp.fr for enrollment information.
Where is the NCT06150703 trial being conducted?
This trial is being conducted at Bondy, France.
Who is sponsoring the NCT06150703 clinical trial?
NCT06150703 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 652 participants.