drugset / Trial / NCT02493933

Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients

NCT02493933

Phase 1 Unknown 240 enrolled Kasr El Aini Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Group A, \[PE group, n= 80\] patients received CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, \[ISMN group, n=80\] received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, \[NAC group, n=80\] patients received CC 100 mg/d plus NAC 1200 mg/day.

Timeline

Start
2015-07
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Black Cohosh Traditional medicine (herbal / TCM) 120 mg Oral
Comparator Isosorbid mononitrate Unknown 20 mg Other
Comparator N-acetylcysteine Small molecule 1200 mg Oral

Indications