Back to resultsCoenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coenzyme Q10
clomiphene citrate
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring pcos, coenzymeQ10, clomiphene citrate
Eligibility 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
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coenzyme Q10/CC group
CC alone group
Arm Description
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
Intervention: CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6
Outcomes
Primary Outcome Measures
Number of ovulating patients
Secondary Outcome Measures
Number of pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910766
Brief Title
Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome
Official Title
Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
pcos, coenzymeQ10, clomiphene citrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coenzyme Q10/CC group
Arm Type
Experimental
Arm Description
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
Arm Title
CC alone group
Arm Type
Active Comparator
Arm Description
Intervention:
CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCG
Intervention Description
no more details
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Primary Outcome Measure Information:
Title
Number of ovulating patients
Time Frame
1-2 months
Secondary Outcome Measure Information:
Title
Number of pregnancies
Time Frame
1-2 months
Other Pre-specified Outcome Measures:
Title
Number of miscarriages
Time Frame
1 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
24813752
Citation
El Refaeey A, Selem A, Badawy A. Combined coenzyme Q10 and clomiphene citrate for ovulation induction in clomiphene-citrate-resistant polycystic ovary syndrome. Reprod Biomed Online. 2014 Jul;29(1):119-24. doi: 10.1016/j.rbmo.2014.03.011. Epub 2014 Mar 26.
Results Reference
derived
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Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome
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