Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles

Infertility Clinical Trial

— cc versus FSH  

Official title:

Among Non-IVF Patients Undergoing Ovulation Induction With Clomiphene Citrate (Clomid® 50 mg), Does Administration of an Increased Dose of Clomiphene Citrate (Clomid® 100 mg) Compared With Gonadotropins, Achieve Similar Rates of Folliculogenesis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835744
• Other study ID #: 2008/192
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2009
• Last updated: March 27, 2012
• Start date: August 2008
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• < 39 years old on day of randomisation

• FSH < 12 (in the early follicular phase)

• Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.

• Chronic oligo or anovulation (WHO 2)

• BMI between 18 and 31 (both inclusive)

Exclusion Criteria:

• = 39 years old on day of randomisation

Study Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• clomiphene citrate
ovulation induction
• gonadotropins
ovulation induction

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	folliculogenesis		april 2009	No
Secondary	pregnancy rate		april 2009	No