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Trial record 74 of 566 for:    "Polycystic Ovary Syndrome"

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

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ClinicalTrials.gov Identifier: NCT01910766
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
ahmed M. badawy, 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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Coenzyme Q10 Drug: clomiphene citrate Not Applicable

Detailed Description:
No more details

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013


Arm Intervention/treatment
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

Drug: Coenzyme Q10
no more details
Other Name: CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCG

Drug: clomiphene citrate
Active Comparator: CC alone group

Intervention:

CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6

Drug: clomiphene citrate



Primary Outcome Measures :
  1. Number of ovulating patients [ Time Frame: 1-2 months ]

Secondary Outcome Measures :
  1. Number of pregnancies [ Time Frame: 1-2 months ]

Other Outcome Measures:
  1. Number of miscarriages [ Time Frame: 1 month ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910766


Locations
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Egypt
Mansoura University Hospitals
Mansoura, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mansoura University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ahmed M. badawy, Professor of Obstetrics & Gynecology, Mansoura University
ClinicalTrials.gov Identifier: NCT01910766     History of Changes
Other Study ID Numbers: CoQ10
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by ahmed M. badawy, Mansoura University:
pcos
coenzymeQ10
clomiphene citrate

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Ubiquinone
Coenzyme Q10
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents