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

GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.

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.

Study Overview

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

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
    • Ibnrochd Clinic
  • Constantine, Algeria, 25000
    • Ibnrochd IVF center

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 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 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
No Intervention: Control; No intervention
Experimental: GnRH agonist; 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	Drug: Triptorelin 0.1 mg; a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.; Other Names: Decapeptyl 0.1 mg

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	Time Frame: 5 weeks after IVF/ICSI

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovarian hyperstimulation syndrome OHSS	early and late onset Ovarian hyper stimulation syndrome	Time Frame: from date of triggering until 2 weeks after pregnancy test]

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Ibn Rochd
• Investigators: Principal Investigator: Abdelhamid Benmachiche, M.D, Ibn roch infertility centre, cité boussouf, Constantine Algeria

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: IVF; GnRH agonist trigger; Luteal phase support; Mid-luteal GnRH agonist
• 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: 02053779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No