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

Overview

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.

Full Title of Study: “Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 2013

Detailed Description

No more details

Interventions

  • Drug: Coenzyme Q10
    • no more details
  • Drug: clomiphene citrate

Arms, Groups and Cohorts

  • Experimental: Coenzyme Q10/CC group
    • 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
  • Active Comparator: CC alone group
    • Intervention: CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6

Clinical Trial Outcome Measures

Primary Measures

  • Number of ovulating patients
    • Time Frame: 1-2 months

Secondary Measures

  • Number of pregnancies
    • Time Frame: 1-2 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ahmed M. badawy, Professor of Obstetrics & Gynecology – Mansoura University

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