drugset / Trial / NCT04870502

Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance

NCT04870502

Phase 2/3 Completed 161 enrolled Saudi German Hospital - Madinah
RandomizedParallel-groupOpen-labelTreatment

Summary

Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant PCOS patients. Methods: 148 PCOS Patients with Clomiphene Citrate resistance were randomized into two groups (A and B). In group A, controlled ovarian stimulation was done by Clomiphene Citrate 150 mg daily (from 2nd till 6th day of cycle) together with Ubiquinol starting from 2nd day till day of hCG triggering in a dose of 100 mg orally once daily. In group B, hMG was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU. Serial transvaginal ultrasonography was done starting on cycle day 8 and continued till size of leading follicle reaches 18 mm or more then ovulation triggering was done. Thereafter, patients were advised for a timed intercourse (TI) after 36 hours. A blood sample was withdrawn seven days after hCG triggering, for measurement of serum progesterone. If the Patient presented with a missed period for one week, a serum sample was sent for β-hCG.

Timeline

Start
2019-04-01
Primary completion
2020-07-31
Completion
2020-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified 150 mg
Comparator Human Menopausal Gonadotropins Unknown 75 iu Intramuscular
Comparator Human Menopausal Gonadotropins Unknown 225 iu Intramuscular
Comparator Ubiquinol Unknown 100 mg Oral
Comparator human chorionic gonadotropin Protein / enzyme biologic 10000 iu Intramuscular