Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS

November 23, 2020 updated by: samia husain, Karachi Medical and Dental College

Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome

The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Aziz medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of polycystic ovarian syndrome 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:

  • Non-consenting.
  • known autoimmune disorders
  • prior treatment of endometriosis or surgery to reproductive tract
  • prior history of pelvic inflammatory disease
  • those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram.
  • Thyroid disorder as assessed by history examination and TSH level
  • Patients with raised FSH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clomiphene
clomiphene citrate 150 mg once a day for 5 days
Drug: clomiphene citrate
ovulation induction drug
Other Names:
  • clomid
Experimental: clomiphene and coenzyme q10
clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
Drug: clomiphene citrate
ovulation induction drug
Other Names:
  • clomid
Drug: Coenzyme Q10
antioxidant used to decrease oxidative stress and improve fertility prospects
Other Names:
  • celeron sr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of ovulating women
Time Frame: 1-2 months
transvaginal ultrasound as the disappearance of the leading follicle, presence of follicular fluid in the Douglas pouch and midluteal progesterone >5 pg/ml.
1-2 months
number of pregnancies
Time Frame: 1-2 months
ultrasound visualization of gestational sac with pulsating fetal pole
1-2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karachi Medical and Dental College

Investigators

  • Study Director: Rubina Izhar, Aziz medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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