NCT01672801

Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston IVF · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Unexplained Infertility
• Polycystic Ovarian Syndrome
• Anovulatory

Interventions

Type	Name	Description
DRUG	Placebo	oral administration
DRUG	Nimodipine	oral administration

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-08-27
• Last updated: 2020-08-11
• Results posted: 2020-08-11

Locations

1 site across 1 country: United States