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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Maeliss Peigné
RECRUITING
Bondy
Contact Information
Primary
Maeliss Peigné, MCU-PH
maeliss.peigne@aphp.fr
01 48 02 68 56
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2027-09-27
Participants
Target number of participants: 652
Treatments
Active_comparator: Ovulation triggering with hCG + Luteal phase support with vaginal progesterone
hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg tid) vaginally from the evening of the oocyte retrieval until the first pregnancy test
Experimental: Ovulation triggering with Triptorelin + Luteal phase support with 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
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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