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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
clomiphene citrate
gonadotropins
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ovulation induction, clomiphene citrate, gonadotropins

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept 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)

Exclusion Criteria:

  • ≥ 39 years old on day of randomisation

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

folliculogenesis

Secondary Outcome Measures

pregnancy rate

Full Information

First Posted
February 3, 2009
Last Updated
March 27, 2012
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT00835744
Brief Title
Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovulation induction, clomiphene citrate, gonadotropins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Intervention Description
ovulation induction
Intervention Type
Drug
Intervention Name(s)
gonadotropins
Intervention Description
ovulation induction
Primary Outcome Measure Information:
Title
folliculogenesis
Time Frame
april 2009
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
april 2009

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

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Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles

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