Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles - Full Text View

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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Universitair Ziekenhuis Brussel. Recruitment status was Recruiting

First Received on February 3, 2009. No Changes Posted

Sponsor:	Universitair Ziekenhuis Brussel
Information provided by:	Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:	NCT00835744

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 IV

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:

MedlinePlus related topics: Infertility

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Citric acid Clomiphene Sodium Citrate trans-Clomifene citrate

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835744

Contacts

Contact: Christophe blockeel

+3224776699

cblockee@uzbrussel.be

Locations

Belgium
UZ Brussel	Recruiting
Jette, Belgium, 1090
Contact: christophe blockeel, MD +3224776699 cblockee@uzbrussel.be

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

More Information

No publications provided

Responsible Party:	Paul Devroey, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:	NCT00835744 History of Changes
Other Study ID Numbers:	2008/192
Study First Received:	February 3, 2009
Last Updated:	February 3, 2009
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 February 09, 2012