Polycystic Ovarian Syndrome Clinical Trial
— NIMOOfficial 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
NCT number | NCT01672801 |
Other study ID # | 2012P-000186 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | April 2014 |
Verified date | August 2020 |
Source | Boston IVF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston IVF | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston IVF | Village Fertility Pharmacy |
United States,
Chen EC, Javors MA, Norris C, Siler-Khodr T, Schenken RS, King TS. Dependence of 3',5'-cyclic adenosine monophosphate--stimulated gonadotropin-releasing hormone release on intracellular calcium levels and L-type calcium channels in superfused GT1-7 neurons. J Soc Gynecol Investig. 2004 Sep;11(6):393-8. — View Citation
Krsmanovic LZ, Stojilkovic SS, Merelli F, Dufour SM, Virmani MA, Catt KJ. Calcium signaling and episodic secretion of gonadotropin-releasing hormone in hypothalamic neurons. Proc Natl Acad Sci U S A. 1992 Sep 15;89(18):8462-6. — View Citation
Núñez L, Villalobos C, Boockfor FR, Frawley LS. The relationship between pulsatile secretion and calcium dynamics in single, living gonadotropin-releasing hormone neurons. Endocrinology. 2000 Jun;141(6):2012-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gonadotropin Levels | Calculated changes in serum LH, FSH, and estradiol levels between patients in nimodipine and placebo arms | Intervention day 0 to ovulation (approximately 1-7 days) | |
Primary | LH Surge | 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). | 7 days | |
Secondary | Number of Participants Experiencing Side Effects | Medication side effect profile including: symptomatic hypotension (Note: vital signs will be recorded), symptomatic tachycardia (Note: vital signs will be recorded), headache, nausea. These will be self-reported with constructed questionnaire. | Starting day 0 of intervention to pregnancy test (approximately 15 days) |
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