Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women|
- LH Concentration [ Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles ] [ Designated as safety issue: No ]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.
- FSH Concentration [ Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 1991|
|Study Completion Date:||March 1994|
|Primary Completion Date:||March 1994 (Final data collection date for primary outcome measure)|
Drug: Clomiphene Citrate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340521
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Carol L Gnatuk, M.D.||a State University Hershey Medical Center /Mayo Clinic when study was conducted|