Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients (nimodipine)
This study is not yet open for participant recruitment.
Verified October 2012 by Mount Sinai Hospital, Canada
Sponsor:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Robert Casper, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01551368
First received: December 15, 2011
Last updated: October 25, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Nimodipine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Using Nimodipine, a Calcium Channel Blocker, to Prevent the LH Surge and Ovulation in Women Undergoing Assisted Reproduction |
Resource links provided by NLM:
Further study details as provided by Mount Sinai Hospital, Canada:
Primary Outcome Measures:
- Delay of LH surge by at least 2 days [ Time Frame: From cycle day 3 until a spontaneous LH surge detected in the blood or the administration of the hCG trigger shot. Estimated time frame is 14 days. ] [ Designated as safety issue: No ]Nimodipine or placebo will be administered four times daily once the criterion for hCG triggering (one or more follicles at 1.7 cm diameter on ultrasound) is present in women being monitored for IUI.
Secondary Outcome Measures:
- Side effect profile of nimodipine or placebo. [ Time Frame: During tablet administration at mid-cycle. ] [ Designated as safety issue: Yes ]Any side effects (especially related to low blood pressure) will be reported by the subjects and recorded by the study investigators during the administration of nimodipine or placebo.
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nimodipine
Nimodipine 30 mg tablets will be self-administered by the subjects every 6 hours starting on the day that the ultrasound criterion for hCG triggering is met. The tablets will be taken for two days or until an LH surge is detected, whichever comes first. If no LH surge by 2 days, the hCG trigger (250 micrograms recombinant hCG) will be given followed by intrauterine insemination (IUI)in 40 hours. If the LH surge is detected, hCG will be given immediately and two IUIs will be performed 24 hours apart.
|
Drug: Nimodipine
Nimodipine 30 mg tablets will be self-administered by the subjects every 6 hours starting on the day that the ultrasound criterion for hCG triggering is met. The tablets will be taken for two days or until an LH surge is detected, whichever comes first. If no LH surge by 2 days, the hCG trigger (250 micrograms recombinant hCG) will be given followed by intrauterine insemination (IUI)in 40 hours. If the LH surge is detected, hcg will be given immediately and two IUIs will be performed 24 hours apart.
Other Name: Nimotop
|
|
Placebo Comparator: Placebo
Same as for nimodipine but an identical placebo will be self-administered.
|
Drug: Placebo
Identical inactive tablets.
Other Name: placebo tablets
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 25 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551368
Contacts
| Contact: Robert F Casper, MD | 416-972-0777 | casper@lunenfeld.ca |
Locations
| Canada, Ontario | |
| Toronto Centre for Advanced reproductive Technology (TCART) | Not yet recruiting |
| Toronto, Ontario, Canada, M5S2X9 | |
| Contact: Robert F Casper, MD 416-972-0777 casper@lunenfeld.ca | |
| Contact: Yaakov Bentov, MD 416-972-0110 bentov@lunenfeld.ca | |
| Principal Investigator: Robert F Casper, MD | |
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
| Principal Investigator: | Robert F Casper, MD | Toronto Centre for Advanced Reproductive Technology and University of Toronto |
More Information
No publications provided
| Responsible Party: | Robert Casper, Professor, Obstetrics and Gynecology, Mount Sinai Hospital, Canada |
| ClinicalTrials.gov Identifier: | NCT01551368 History of Changes |
| Other Study ID Numbers: | 09-0175-A |
| Study First Received: | December 15, 2011 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Mount Sinai Hospital, Canada:
|
male factor intrauterine insemination LH surge controlled ovarian stimulation |
clomiphene citrate letrozole human menopausal gonadotropins |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Calcium Channel Blockers Nimodipine Menotropins Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013