GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Triptorelin 0.1mg

• Registration Number: NCT02053779
• Lead Sponsor: Centre Hospitalier Universitaire Ibn Rochd

Brief Summary

Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

Acronyms:

GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride

Detailed Description

It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 328

Inclusion Criteria

• Female age < 40 years
• Baseline FSH and LH < 12 IU/l.
• Body Mass Index > 18 and < 35 kg/m2
• No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
• Patients with at least one embryo at transfer time

Exclusion Criteria

• Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering).
• Reduced ovarian reserve
• Fertilization failure
• Severe endocrinopathy
• Azoospermia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH-agonist	Triptorelin 0.1mg	Experimental Arm: Triptorelin 0.1 mg

Primary Outcome Measures

Name	Time	Method
implantation rate	5 weeks after IVF/ICSI	number of gestational sacs per number of embryos transferred

Secondary Outcome Measures

Name	Time	Method
chemical pregnancy	2 weeks after IVF/ICSI	confirmed by beta-hCG 14 days post embryo transfer
live birth	26 weeks after IVF/ICSI	birth of baby beyond 28 weeks of gestation
clinical pregnancy	5 weeks after IVF/ICSI	appearance of yolk sac with foetal heart beat at 7 weeks of gestation

Trial Locations

Locations (1)

Ibn Rochd Infertility Centre; 🇩🇿 Constantine, Algeria