Clinical Trials Logo

Clinical Trial 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 Trial Description

After enrollment, subjects will be randomized to Placebo Comparator or Active Comparator. All subjects will receive Clomid 100 mg for 5 days for the purpose of ovarian follicle recruitment. Intervention will be initiated once ovarian follicle maturation has been documented (≥1 ovarian follicle size of ≥ 17mm) and the absence of a premature LH surge has been confirmed - this will be classified as intervention day 0. Subjects will receive their assigned comparator (Placebo or Active) according the schedule below:

- Intervention Day 0 - noon / afternoon / bedtime (3 doses)

- Intervention Day 1 - morning / noon / afternoon / bedtime (4 doses)

- Intervention Day 2 - morning (1 dose) Serum hormone levels and ultrasound examination will occur on days 0,1 and 2 for all subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01672801
Study type Interventional
Source Boston IVF
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date April 2014

See also
  Status Clinical Trial Phase
Recruiting NCT02244567 - Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women Phase 1
Completed NCT01653743 - Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women Phase 3
Completed NCT00579540 - Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels N/A
Terminated NCT05084274 - Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program N/A
Completed NCT03717935 - Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS N/A
Withdrawn NCT01716429 - Healthy Eating for Reproductive Health: Greenville N/A
Active, not recruiting NCT02896452 - Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome
Recruiting NCT05146063 - LNK in Polycystic Ovary Syndrome With Insulin Resistance
Recruiting NCT06303219 - Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome N/A
Completed NCT02869750 - The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome
Completed NCT01237106 - In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT01185704 - Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) Phase 3
Recruiting NCT04029805 - Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels Phase 1/Phase 2
Completed NCT01675843 - Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome Phase 4
Completed NCT01577017 - The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS) Phase 3
Completed NCT00478504 - Letrozole Versus Clomifene Citrate for Ovulation Induction Phase 4
Completed NCT05215223 - Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome N/A
Completed NCT03358199 - LOD Before IVF/ICSI in PCOS Patients With High AMH N/A
Completed NCT02436226 - Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS Phase 4
Recruiting NCT02084940 - Long Acting GnRH Antagonist in PCOS Women Undergoing IVF N/A