NCT02703584

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation- A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

Summary

All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

Detailed description

A prospective, randomized, double blinded clinical trial. Patients will undergo standard clinical and hormonal investigation as usual for IVF. Patients that will be given the standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1. hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36 hours prior to the oocyte aspiration. All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support. In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta error of 80% the sample size needed is 276 total patients in both groups or 138 patients in each group.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Buseralin
OTHER	Placebo
DRUG	pregnyl

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-03-09
• Last updated: 2022-04-28

Locations

1 site across 1 country: Canada