- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302532
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
-
-
Sindh
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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
18 years to 33 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
|
ovulation induction drug
Other Names:
|
Experimental: clomiphene and coenzyme q10
clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
|
ovulation induction drug
Other Names:
antioxidant used to decrease oxidative stress and improve fertility prospects
Other Names:
|
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.
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Micronutrients
- Hormone Antagonists
- Vitamins
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Coenzyme Q10
- Clomiphene
- Enclomiphene
- Zuclomiphene
- Ubiquinone
Other Study ID Numbers
- 1
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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