Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Clomiphene Citrate (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Milton S. Hershey Medical Center Official(s) and/or principal investigator(s): Carol L Gnatuk, M.D., Principal Investigator, Affiliation: a State University Hershey Medical Center /Mayo Clinic when study was conducted
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.
Clinical Details
Official title: FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: LH Concentration
Secondary outcome: FSH Concentration
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: March 1991
Last updated: December 19, 2012
|