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Completed

NCT Number: NCT01340521

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene Citrate

Drug

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

Primary outcomes

  1. LH Concentration

    Time frame: 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 outcomes

  1. FSH Concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Important dates

Study start
1991
Primary completion
1994
Study completion
1994
First posted
Apr 22, 2011
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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