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Completed

NCT Number: NCT01910766

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

No more details

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10

Drug

no more details

Other names: CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCG

Clomiphene Citrate

Drug

Primary outcomes

  1. Number of ovulating patients

    Time frame: 1-2 months

Secondary outcomes

  1. Number of pregnancies

    Time frame: 1-2 months

Other outcomes

  1. Number of miscarriages

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2013
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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