Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

Phase 4

• Conditions: Infertility
• Interventions: Drug: rHCG 250ug; Drug: uHCG 7500 IU; Drug: uHCG 5000 IU

• Registration Number: NCT00415766
• Lead Sponsor: Eugonia

Brief Summary

The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Detailed Description

Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.

Study Timeline

• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-23
• Study First Posted: 2006-12-25
• Study Start: 2013-06
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• At least 14 follicles >11mm on the day of triggering final oocyte maturation
• Pretreated with GnRH antagonist protocol

Exclusion Criteria

• Poor responders
• Women with 25 or more follicles on the day of trigger

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rHCG 250 ug	rHCG 250ug	Injection of 250 ug Ovitrelle to trigger final oocyte maturation
uHCG 7500 IU	uHCG 7500 IU	Injection of 7500 IU Pregnyl to trigger final oocyte maturation
uHCG 5000 IU	uHCG 5000 IU	Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Primary Outcome Measures

Name	Time	Method
Percentage of mature oocytes	Day of oocyte retrieval (Day 0)	Percentage MII/COCs

Secondary Outcome Measures

Name	Time	Method
Positive test per embryo transfer	15 days post oocyte retrieval
Clinical pregnancy per embryo transfer	7 weeks of gestation
Ongoing pregnancy per embryo transfer	12 weeks of gestation
Level of serum hCG on day of oocyte retrieval	Day of oocyte retrieval
Number of oocytes (COC) retrieved	Day of oocyte retrieval
Number of mature oocytes (MII)	Day of oocyte retrieval
Oocyte retrieval rate	Day of oocyte retrieval (Day 0)	Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation
Incidence of severe early OHSS	up to Day 5 post oocyte retrieval

Trial Locations

Locations (1)

Eugonia; 🇬🇷 Athens, Greece