cc versus FSH: Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Completed

CT.gov ID

NCT00835744

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: clomiphene citrate Drug: gonadotropins	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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?

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, an increased dose of 100 mg of clomiphene citrate is administered from day 13 until day 17 of the cycle.	Drug: clomiphene citrate ovulation induction
Active Comparator: B Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, gonadotropins (75IU) are administered from day 13 until day 17 of the cycle.	Drug: gonadotropins ovulation induction

Arm

Intervention/Treatment

Placebo Comparator: A

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, an increased dose of 100 mg of clomiphene citrate is administered from day 13 until day 17 of the cycle.

Drug: clomiphene citrate

ovulation induction

Active Comparator: B

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, gonadotropins (75IU) are administered from day 13 until day 17 of the cycle.

Drug: gonadotropins

ovulation induction

Outcome Measures

Primary Outcome Measures

folliculogenesis [april 2009]

Secondary Outcome Measures

pregnancy rate [april 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)