GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

Phase 3

Completed

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

• Registration Number: NCT03039049
• 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.

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 Start: 2014-03
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

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

Inclusion Criteria

Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.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 0.1 mg	Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg. Other Names: • Decapeptyl 0.1 mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
positive pregnancy test	Time Frame: 2 weeks after IVF/ICSI	confirmed by beta-hCG 14 days post embryo transfer
Ongoing pregnancy	Time Frame: 12 weeks after IVF/ICSI	presence of foetal heart beat at 12 weeks of gestation
Delivery rate	Time Frame: 26 weeks after IVF/ICSI	birth of baby beyond 26 weeks of gestation
Early pregnancy loss	Time Frame: miscarriage before 5 weeks of gestation	loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy

Trial Locations

Locations (2)

Ibnrochd IVF center; 🇩🇿 Constantine, Algeria

Ibnrochd Clinic; 🇩🇿 Constantine, Algeria