Polycystic Ovarian Syndrome Clinical Trial
Official title:
Using Nimodipine, a Calcium Channel Blocker, to Prevent LH Surge in Women Undergoing Controlled Ovarian Stimulation and Intrauterine Insemination: a Double-blinded, Randomized Controlled Study
The main purpose of this study is to test the effectiveness of nimodipine in preventing a
luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene
citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation
to allow adequate recruitment of follicles, proper maturation of a dominant follicle before
ovulation, and effectively time insemination with semen to allow fertilization of a mature
egg to occur.
The investigators are also conducting this study to determine medication side effect profile
(including lightheadedness or dizziness from low blood pressure or rapid heart rate,
headache, and nausea), patient treatment compliance, and clinical pregnancy (positive
pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle
stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on
these hormones.
As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of
gonadotropin releasing hormone in animal and preliminary human studies. The investigators
hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge
during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients
undergoing assisted reproduction with intrauterine insemination (IUI).
After enrollment, subjects will be randomized to Placebo Comparator or Active Comparator. All
subjects will receive Clomid 100 mg for 5 days for the purpose of ovarian follicle
recruitment. Intervention will be initiated once ovarian follicle maturation has been
documented (≥1 ovarian follicle size of ≥ 17mm) and the absence of a premature LH surge has
been confirmed - this will be classified as intervention day 0. Subjects will receive their
assigned comparator (Placebo or Active) according the schedule below:
- Intervention Day 0 - noon / afternoon / bedtime (3 doses)
- Intervention Day 1 - morning / noon / afternoon / bedtime (4 doses)
- Intervention Day 2 - morning (1 dose) Serum hormone levels and ultrasound examination
will occur on days 0,1 and 2 for all subjects.
;
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