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

Exclusion Criteria

• •Body mass index (BMI) \>38 kg/m2
• •Early follicular phase (day 2-4) serum FSH level ≥20 mIU/mL
• •History of overstimulated cycle defined as \>3 mature follicles of ≥17 mm
• •Abnormal uterine cavity and/or tubal disease (as evidenced by sonohysterogram or hysterosalpingogram)
• •Diagnosis of infertility with a clear indication for in-vitro fertilization, such as bilateral tubal occlusion
• •Severe male factor infertility: Total Motile Sperm Count \< 2x106 post washing (sperm deemed inadequate for IUI preparation)
• •Any ovarian or abdominal abnormality that may interfere with adequate TV ultrasound evaluation
• •Absence of one or both ovaries
• •Any contraindication to being pregnant or carrying a pregnancy to term
• •Unexplained gynecological bleeding
• •Any medical condition that would jeopardize the patient or the integrity of the data obtained including:
• •Prior reaction or side effects from previous calcium channel blocker use
• •Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of nimodipine such as hepatic disease, hypertension, seizure, concurrent infection, depression, reflux (see #12 below).
• •Mental health status resulting in cognitive or emotional impairment that would preclude study participation
• •The concurrent use of any of the following drugs: \[These medications have been shown to effect the availability of the medication or worsen hypotension symptoms\]
• •Antihypertensives (eg. ACE inhibitors, alpha-adrenergic blocking agents,methyldopa, beta-blockers, diuretics, PDE5 inhibitors, and other calcium antagonists)
• •Antiepileptics (eg. phenobarbital, phenytoin, carbamazepine or valproic acid)
• •Macrolide antibiotics (eg, erythromycin)
• •Azole antimycotics (eg, ketoconazole)
• •HIV protease inhibitors (eg, ritonavir)
• •Antidepressants (eg, nefazodone and fluoxetine)
• •Cimetidine
• •Patient unable to communicate adequately with the investigators and to comply with the requirements of the study
• •Unwillingness to give written informed consent