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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


N/A
25 Years
40 Years
Open (Enrolling)
Female
Unexplained Infertility, Polycystic Ovarian Syndrome, Ovulatory Dysfunction (Absence of or Irregular Ovulation With Unknown Cause)

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

LH surge

Outcome Description:

Compare the change between placebo treated and nimodipine treated patients by the presence or absence of an LH surge on intervention Day 1 and Day 2. LH surge will be determined by serum LH levels at least two times the baseline serum LH (baseline serum LH = (cycle day 3 serum [LH] + cycle day 7 serum [LH])/2).

Outcome Time Frame:

The presence or absence of an LH surge after start of intervention

Safety Issue:

No

Principal Investigator

Alan S Penzias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center / Boston IVF

Authority:

United States: Food and Drug Administration

Study ID:

2012P-000186

NCT ID:

NCT01672801

Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Unexplained Infertility
  • Polycystic Ovarian Syndrome
  • Ovulatory Dysfunction (Absence of or Irregular Ovulation With Unknown Cause)
  • Infertility
  • Polycystic Ovary Syndrome

Name

Location

Boston IVFWaltham, Massachusetts  02451