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Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT

Information source: Boston IVF
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unexplained Infertility; Polycystic Ovarian Syndrome; Ovulatory Dysfunction (Absence of or Irregular Ovulation With Unknown Cause)

Intervention: clomiphene citrate (Drug); Placebo (Drug); Nimodipine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Boston IVF

Official(s) and/or principal investigator(s):
Alan S Penzias, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center / Boston IVF

Overall contact:
Khanh-Ha D Nguyen, MD MPH, Phone: 781-484-6500, Email: knguyen@bostonivf.com

Summary

The main purpose of this study is to test the effectiveness of nimodipine in preventing a luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation to allow adequate recruitment of follicles, proper maturation of a dominant follicle before ovulation, and effectively time insemination with semen to allow fertilization of a mature egg to occur.

The investigators are also conducting this study to determine medication side effect profile (including lightheadedness or dizziness from low blood pressure or rapid heart rate, headache, and nausea), patient treatment compliance, and clinical pregnancy (positive pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on these hormones.

As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of gonadotropin releasing hormone in animal and preliminary human studies. The investigators hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients undergoing assisted reproduction with intrauterine insemination (IUI).

Clinical Details

Official title: 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

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

Primary outcome: LH surge

Secondary outcome: Side effect profile

Eligibility

Minimum age: 25 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Khanh-Ha D Nguyen, MD MPH, Phone: 781-484-6500, Email: knguyen@bostonivf.com

Boston IVF, Waltham, Massachusetts 02451, United States; Recruiting
Kristin L. Rooney, BA, Phone: 781-434-6424, Email: krooney@bostonivf.com
Khanh-Ha D Nguyen, MD MPH, Sub-Investigator
Additional Information

Starting date: September 2012
Last updated: October 5, 2012

Page last updated: February 07, 2013

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