Low Dose hCG in the Late Follicular Phase

Infertility Clinical Trial

Official title:

Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750100
• Other study ID #: EC REF 2006-157
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2008
• Last updated: October 8, 2010
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2008
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• human chorionic gonadotropin
hCG 200IU in the late follicular phase
• recombinant gonadotropins
200 IU per day during controlled ovarian stimulation

Locations

Country	Name	City	State
Belgium	UZ Brussel	Laarbeeklaan 101	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes in both treatment groups		up to 9 months	No
Secondary	Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group		up to 9 months	No