Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients

Phase 2

• Conditions: Subfertility
• Interventions: Drug: 0.2 mg triptorelin; Drug: 0.4 mg triptorelin; Drug: 0.1 mg triptorelin

• Registration Number: NCT01973842
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.

Detailed Description

Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.

Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles \>11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.

Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-27
• Study First Posted: 2013-11-01
• Study Start: 2014-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol

• Age < 40 years
• Anticipated high ovarian response

Exclusion Criteria

• Endometriosis > than grade II
• One ovary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.2 mg triptorelin	0.2 mg triptorelin	0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin
0.4 mg triptorelin	0.4 mg triptorelin	0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin
0.1 mg triptorelin	0.1 mg triptorelin	0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin

Primary Outcome Measures

Name	Time	Method
Percentage of mature oocytes retrieved	36 hours post GnRH agonst administration	Percentage of mature oocytes retrieved following oocyte retrieval

Secondary Outcome Measures

Name	Time	Method
oocyte recovery rate	36 hours post GnRH agonist administration
Duration of luteal phase	16 days
total number of oocytes retrieved	36 hours post GnRH agonist administration
Fertilization rate	Day 1 post oocyte retrieval
Serum LH, FSH, E2, PRG levels	8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
OHSS occurrence	16 days post triggering	Occurrence of ovarian hyperstimulation syndrome

Trial Locations

Locations (2)

Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Eugonia IVF Unit; 🇬🇷 Athens, Greece