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

Sponsor

Karachi Medical and Dental College (Other)

Overall Status

Completed

CT.gov ID

NCT04302532

Collaborator

(none)

149

Enrollment

Location

Arms

Actual Duration (Months)

37.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coenzyme q10	Drug: Coenzyme Q10 Drug: clomiphene citrate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

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: Coenzyme Q10 antioxidant used to decrease oxidative stress and improve fertility prospects Other Names: celeron sr Drug: clomiphene citrate ovulation induction drug Other Names: clomid

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: Coenzyme Q10

antioxidant used to decrease oxidative stress and improve fertility prospects

Other Names:

celeron sr

Drug: clomiphene citrate

ovulation induction drug

Other Names:

clomid

Outcome Measures

Primary Outcome Measures

number of ovulating women [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.
number of pregnancies [1-2 months]
ultrasound visualization of gestational sac with pulsating fetal pole

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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