Overview

Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients

Status:
Terminated
Trial end date:
2017-07-01
Target enrollment:
0
Participant gender:
Female
Summary
Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel blockers is fat soluble and therefore is able to cross the blood-brain barrier1. Gonadotropin releasing hormone (GnRH) neurons are clustered in the hypothalamus and are dependent on calcium flux to release GnRH responsible for the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary. In a natural menstrual cycle a spontaneous LH surge occurs mid-cycle which triggers ovulation. The investigators hypothesized that nimodipine, by blocking calcium channels, may effectively suppress the release of GnRH and consequently the natural LH surge. In this prospective double-blinded randomized study the investigators will evaluate the efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled ovarian stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful, may represent an inexpensive oral medication as an alternative to the currently used GnRH agonists or GnRH antagonists in assisted reproductive technologies like IVF.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mount Sinai Hospital, Canada
Treatments:
Calcium Channel Blockers
Nimodipine
Criteria
Inclusion Criteria: Infertility requiring intrauterine insemination

- Age: 25-40 (at time of enrollment)

- Intact Normal Ovaries (Both)

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

- Diagnosis of infertility with a recommended treatment of ovarian stimulation and IUI

Exclusion Criteria:

- BMI > 38 kg/m2

- Early follicular phase (day 2-4) serum FSH level ≥ 20 mIU/ml

- Overstimulated cycle: >3 mature follicles (≥17 mm)

- Abnormal uterine cavity and /or tubal blockage

- Diagnosis of infertility with a clear indication for IVF

- Severe male factor infertility: Total Motile Sperm Count < 2x106 post washing