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

NCT ID: NCT04302532

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coenzyme q10

Keywords

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ovulation induction coenzyme q10 pregnancy rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clomiphene

clomiphene citrate 150 mg once a day for 5 days

Group Type ACTIVE_COMPARATOR

clomiphene citrate

Intervention Type DRUG

ovulation induction drug

clomiphene and coenzyme q10

clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type DRUG

antioxidant used to decrease oxidative stress and improve fertility prospects

clomiphene citrate

Intervention Type DRUG

ovulation induction drug

Interventions

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Coenzyme Q10

antioxidant used to decrease oxidative stress and improve fertility prospects

Intervention Type DRUG

clomiphene citrate

ovulation induction drug

Intervention Type DRUG

Other Intervention Names

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celeron sr clomid

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karachi Medical and Dental College

OTHER

Sponsor Role lead

Responsible Party

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samia husain

clinical investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubina Izhar

Role: STUDY_DIRECTOR

Aziz Medical Center

Locations

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Aziz medical center

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id