Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Ovulation induction with hCG + Luteal phase support with vaginal progesterone
DrughCG 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 by Triptorelin + Luteal phase support by Nafarelin
DrugTriptorelin 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
Treatment groups
652 Participants
are divided into 2 treatment groupsGroup A: Ovulation triggering with hCG + Luteal phase support with vaginal progesteroneActive comparator 1 intervention
Group B: Ovulation triggering with Triptorelin + Luteal phase support with NafarelinExperimental treatment 1 intervention
Trial outcomes
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
Time frame
22 weeks' gestationSecondary outcomes
1
Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG)
Demonstrate improvement of embryo implantation rates with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Time frame
5-8 weeks' gestation2
Pregnancy defined as an hCG level > 10 IU/ml 14 days after oocyte retrieval.
Demonstrate an improvement in pregnancy rate with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Time frame
14 days after oocyte retrieval.3
Clinical pregnancy, defined as an intrauterine gestational sac with embryo showing cardiac activity on ultrasound at 5-10 WG
Demonstrate an improvement in clinical pregnancy rate with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Time frame
5-10 weeks' gestation4
Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG.
Demonstrate a decrease in the rate of miscarriage per pregnancy with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Time frame
12 weeks' gestationSponsors and contacts
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Source ClinicalTrials.gov