Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Mount Sinai Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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, Female
Genital Diseases, Male
Calcium Channel Blockers
Nimodipine
Antihypertensive Agents
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014