Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

December 19, 2012 updated by: Milton S. Hershey Medical Center

FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

The goal of the study is to quantitatively evaluate pituitary hormone response, follicle stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in normally fertile women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance fecundity in women with unexplained infertility. No clinical trials have examined the efficacy of such treatment in the patient population, although certain studies have shown that active ovulation induction can be effective in women with unexplained infertility, and that cycle fecundity is improved for normally cycling women with active ovulation management in a program of artificial insemination. Since clomiphene citrate can have paradoxical effects on fertility through its anti-estrogenic mode of action, the benefit or lack of benefit from treatment with clomiphene citrate in this patient group needs to be evaluated. We aim to establish a dose response of FSH and LH to various low doses of clomiphene citrate in normally cycling women of known fertility, that is women with an intact hypothalamic-pituitary-ovarian-axis. The significance of this information is that it may help to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in patients with unexplained infertility as it is currently being used empirically.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal cycling healthy women with known fertility
  • Regular menses every 24 - 35 days
  • 18 to 35 years of age
  • be within 20% of ideal body weight
  • normal TSH, prolactin and mid luteal phase progesterone

Exclusion Criteria:

  • Women with Infertility issues
  • Irregular menstrual cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LH Concentration
Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles
LH will be measured from blood samples of approximately 10 mL from each subject on cycle day 3 and then daily on cycle day 5 through ovulation as determined by urinary LH testing kit and every 3rd day until menses occur.
Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSH Concentration
Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles
FSH will be measured from blood samples of approximately 10mL from each subject on cycle day 3, then daily from cycle day 5 through ovulation as determined by urinary testing kit and every third day until menses occur.
Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Mayo Clinic

Investigators

  • Principal Investigator: Carol L Gnatuk, M.D., a State University Hershey Medical Center /Mayo Clinic when study was conducted

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1991

Primary Completion (Actual)

March 1, 1994

Study Completion (Actual)

March 1, 1994

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214-91

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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