Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Coenzyme Q10; Drug: clomiphene citrate

• Registration Number: NCT01910766
• Lead Sponsor: Mansoura University

Brief Summary

Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.

Detailed Description

No more details

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-29
• Last Update Submitted: 2013-07-29
• Study First Posted: 2013-07-30
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
• All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium <5 mm at the time of hCG administration

Exclusion Criteria

• patients with hyperprolactinaemia,
• hypercorticism and
• thyroid dysfunction.
• patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10/CC group	Coenzyme Q10	Intervention: Coenzyme Q10 (CoQ10) and clomiphene citrate group (55 patients, 82 cycles) Patients in CoQ10/CC group took CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6, and CoQ10 Mepaco, Enshas Elraml, Sharkhia, Egypt), in a dose of 60 mg 3 times day capsules orally starting on cycle day 2 and continued till the day of human chorionic gonadotropin (hCG) administration
CC alone group	clomiphene citrate	Intervention: CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6
Coenzyme Q10/CC group	clomiphene citrate	Intervention: Coenzyme Q10 (CoQ10) and clomiphene citrate group (55 patients, 82 cycles) Patients in CoQ10/CC group took CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6, and CoQ10 Mepaco, Enshas Elraml, Sharkhia, Egypt), in a dose of 60 mg 3 times day capsules orally starting on cycle day 2 and continued till the day of human chorionic gonadotropin (hCG) administration

Primary Outcome Measures

Name	Time	Method
Number of ovulating patients	1-2 months

Secondary Outcome Measures

Name	Time	Method
Number of pregnancies	1-2 months

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlia, Egypt