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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00835744
First received: February 3, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Infertility
Drug: clomiphene citrate
Drug: gonadotropins
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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?

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • folliculogenesis [ Time Frame: april 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: april 2009 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00835744

Locations
Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

No publications provided

Responsible Party: Blockeel Christophe, Dr, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00835744     History of Changes
Other Study ID Numbers: 2008/192
Study First Received: February 3, 2009
Last Updated: March 27, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
ovulation induction
clomiphene citrate
gonadotropins

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Clomiphene
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on July 22, 2014