NCT01910766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3 years

First QC Date

July 19, 2013

Last Update Submit

July 29, 2013

Conditions

Polycystic Ovary Syndrome

Keywords

pcoscoenzymeQ10clomiphene citrate

Outcome Measures

Primary Outcomes (1)

  • Number of ovulating patients

    1-2 months

Secondary Outcomes (1)

  • Number of pregnancies

    1-2 months

Other Outcomes (1)

  • Number of miscarriages

    1 month

Study Arms (2)

Coenzyme Q10/CC group

EXPERIMENTAL

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 Q10Drug: clomiphene citrate

CC alone group

ACTIVE COMPARATOR

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

Drug: clomiphene citrate

Interventions

Coenzyme Q10DRUG

no more details

Also known as: CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCG
Coenzyme Q10/CC group
clomiphene citrateDRUG
CC alone groupCoenzyme Q10/CC group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 24813752DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

coenzyme Q10Clomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 30, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

EG(1)