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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340521
• Other study ID #: 214-91
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 18, 2011
• Last updated: December 19, 2012
• Start date: March 1991
• Est. completion date: March 1994

Study information

• Verified date: December 2012
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 1994
• Est. primary completion date: March 1994
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles	No
Secondary	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.	Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles	No