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

Karachi Medical and Dental College

Status and phase: Completed; Phase 4

Conditions: Coenzyme q10

Treatments: Drug: Coenzyme Q10; Drug: clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04302532

1

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 2 patient groups

Clomiphene

Active Comparator group

Description:

clomiphene citrate 150 mg once a day for 5 days

Treatment:

Drug: clomiphene citrate

clomiphene and coenzyme q10

Experimental group

Description:

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

Treatment:

Drug: clomiphene citrate

Drug: Coenzyme Q10