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