Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day

Phase 4

Completed

• Conditions: Infertility
• Interventions: Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin

• Registration Number: NCT02397551
• Lead Sponsor: Cairo University

Brief Summary

To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• High responder females undergoing antagonist protocol IVF/ICSI cycle
• More than 14 MII oocytes
• Estradiol more than 3500 pg/ml on day of trigger

Exclusion Criteria

• Any other protocol
• Normal or poor responders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Small doses of HCG	Human Chorionic Gonadotropin	Supplementing the luteal phase with three small doses (500 IU) of HCG after trigger with GnRH agonist in antagonist IVF/ICSI cycles in high responders
Booster HCG dose	IVF/ICSI	Booster HCG dose GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup
Small doses of HCG	IVF/ICSI	Supplementing the luteal phase with three small doses (500 IU) of HCG after trigger with GnRH agonist in antagonist IVF/ICSI cycles in high responders
Booster HCG dose	Human Chorionic Gonadotropin	Booster HCG dose GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	1 year	The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test

Secondary Outcome Measures

Name	Time	Method
OHSS rate	1 year	The number of cycles with evidence of OHSS

Trial Locations

Locations (3)

Nile IVF center; 🇪🇬 Giza, Egypt

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini); 🇪🇬 Cairo, Egypt

Adam International hospital; 🇪🇬 Giza, Egypt