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

NCT06150703 | Recruiting Phase 3 DMC

• 1 other identifier: APHP220667
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

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).

Conditions

In Vitro Fertilization; ICSI Intracytoplasmic Spermatozoid Injection

Keywords

GnRH agonist triggering; GnRH agonist luteal phase support,; pregnancy; live birth

Outcome Measures

Primary Outcomes (1)

• Live birth, defined as the presence of a live birth after 22 weeks' gestation. Twin pregnancies will be counted as a single birth.

  To demonstrate an increase in the rate of live births after 22 weeks' amenorrhoea (SA) per cycle with induction and support by GnRH agonist compared with the reference protocol combining induction by hCG and luteal support by exogenous vaginal progesterone

  22 weeks' gestation

Secondary Outcomes (29)

• Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG)

  5-8 weeks' gestation

• Pregnancy defined as an hCG level > 10 IU/ml 14 days after oocyte retrieval.

  14 days after oocyte retrieval.

• Clinical pregnancy, defined as an intrauterine gestational sac with embryo showing cardiac activity on ultrasound at 5-10 WG

  5-10 weeks' gestation

• Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG.

  12 weeks' gestation

• Ongoing pregnancy, defined as the presence of an intra-uterine sac with an embryo with cardiac activity visible on ultrasound between 11 weeks of gestations(WG) and 13 WG+6 days (first trimester ultrasound).

  first trimester ultrasound (11 weeks of gestation and 13weeks of gestation +6days)

Study Arms (2)

Ovulation triggering with hCG + Luteal phase support with vaginal progesterone

ACTIVE COMPARATOR

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

Drug: Ovulation induction with hCG + Luteal phase support with vaginal progesterone

Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin

EXPERIMENTAL

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

Drug: Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin

Interventions

Ovulation induction with hCG + Luteal phase support with vaginal progesterone DRUG

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

Ovulation triggering with hCG + Luteal phase support with vaginal progesterone

Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin DRUG

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

Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Maeliss Peigné

Bondy, France

RECRUITING

MeSH Terms

Interventions

Ovulation Induction

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Central Study Contacts

Maeliss Peigné, MCU-PH

CONTACT

01 48 02 68 56; maeliss.peigne@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: November 29, 2023
• Study Start: June 27, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 27, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)