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

Phase 1

Completed

• Conditions: Infertility

• Registration Number: NCT01340521
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 1991-03
• Primary Completion: 1994-03
• Study Completion: 1994-03
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-22
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
LH Concentration	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.

Secondary Outcome Measures

Name	Time	Method
FSH Concentration	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States