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NCT01672801 · ClinicalTrials.gov registry record · NA
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT
A NA study, sponsored by Boston IVF.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT01672801: Completed NA study, sponsored by Boston IVF.
NCT01672801 is a NA study that has completed, run by Boston IVF. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01672801, a NA study, has completed, sponsored by Boston IVF.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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).
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Nimodipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01672801 record still lists
NCT01672801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01672801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01672801 about?
NCT01672801 is a clinical study titled "Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT". 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 ...
What is the current status of trial NCT01672801?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2012-09. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01672801?
The interventions under investigation include: Placebo (DRUG), Nimodipine (DRUG).
Who is sponsoring clinical trial NCT01672801?
This trial is sponsored by Boston IVF, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01672801's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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