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

The Impact of a Single Dose of GnRH Agonist (Triptorelin 0,1 mg) at the Time of Implantation on the Reproductive Outcome in IVF Cycles Triggered by a GnRH Agonist Followed by a Small Bolus of HCG the Day of Oocyte Retrieval

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Triptorelin 0.1mg

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 Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Algeria
  • Constantine, Algeria, 25000
    • Ibn Rochd Infertility Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GnRH-agonist; Experimental Arm: 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 followed by hCG 1500 iu the day of OPU.; Other Names: Decapeptyl 0.1 mg
No Intervention: Control Arm; Control Arm: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implantation rate	number of gestational sacs per number of embryos transferred	5 weeks after IVF/ICSI

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovarian hyperstimulation syndrome OHSS	frequency of moderate to severe OHSS	from date of triggering until 2 weeks after pregnancy test

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Ibn Rochd
• Investigators: Principal Investigator: Abdelhamid benmachiche, Doctor, Ibn roch infertility centre, cité boussouf, Constantine Algeria

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: GnRH agonist; GnRH antagonist; Luteal phase
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: 27111969

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No