Low Dose hCG in the Late Follicular Phase

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: recombinant gonadotropins; Drug: human chorionic gonadotropin

• Registration Number: NCT00750100
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Study Completion: 2008-11
• Last Update Submitted: 2010-10-08
• Last Update Posted: 2010-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• < 36 years on day of randomisation
• FSH < 12 in the early follicular phase
• Normal ultrasound scan
• BMI between 18 and 29 (both inclusive)
• Randomisation at outpatient clinic

Exclusion Criteria

• Endometriosis ≥ grade 3
• PCO syndrome
• Poor responder
• Endocrine or metabolic abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	recombinant gonadotropins	Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
B	human chorionic gonadotropin	Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.

Primary Outcome Measures

Name	Time	Method
Number of oocytes in both treatment groups	up to 9 months

Secondary Outcome Measures

Name	Time	Method
Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group	up to 9 months

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Laarbeeklaan 101, Brussels, Belgium