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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Clomiphene Citrate

About this trial

This is an interventional treatment trial for Infertility focused on measuring Pituitary Hormone Response, Clomiphene Citrate, Follicle Stimulating Hormone, Luteinizing Hormone

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic

Outcomes

Primary Outcome Measures

LH Concentration

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.

Secondary Outcome Measures

FSH Concentration

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.

Full Information

NCT ID

NCT01340521

First Posted

April 18, 2011

Last Updated

December 19, 2012

Sponsor

Milton S. Hershey Medical Center

Collaborators

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01340521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 1991 (undefined)

Primary Completion Date

March 1994 (Actual)

Study Completion Date

March 1994 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Milton S. Hershey Medical Center

Collaborators

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Pituitary Hormone Response, Clomiphene Citrate, Follicle Stimulating Hormone, Luteinizing Hormone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clomiphene Citrate

Intervention Description

0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.

Primary Outcome Measure Information:

Title

LH Concentration

Description

Time Frame

Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

Secondary Outcome Measure Information:

Title

FSH Concentration

Description

Time Frame

Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol L Gnatuk, M.D.

Organizational Affiliation

a State University Hershey Medical Center /Mayo Clinic when study was conducted

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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