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

Inclusion Criteria:

- Age 25-40 years at the time of enrollment

- Both ovaries intact by history and ultrasound assessment

- Early follicular phase (day 2-4) serum FSH level <20 mIU/mL

- Diagnosis of subfertility with a recommended treatment of COH and IUI

- Providing written informed consent in English

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