Clinical trial · Interventional
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anovulatory | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
| Unexplained Infertility | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimodipine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Nimodipine
- description
- All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes
- interventionNames
- Drug: Nimodipine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDChen 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. doi: 10.1016/j.jsgi.2004.02.010. PMID 15350253
- BACKGROUNDKrsmanovic 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. doi: 10.1073/pnas.89.18.8462. PMID 1326758
- BACKGROUNDNunez 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. doi: 10.1210/endo.141.6.7491. PMID 10830284