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

Phase 4

Completed

• Conditions: Coenzyme q10
• Interventions: Drug: clomiphene citrate; Drug: Coenzyme Q10

• Registration Number: NCT04302532
• Lead Sponsor: Karachi Medical and Dental College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2020-07-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene	clomiphene citrate	clomiphene citrate 150 mg once a day for 5 days
clomiphene and coenzyme q10	Coenzyme Q10	clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
clomiphene and coenzyme q10	clomiphene citrate	clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aziz medical center; 🇵🇰 Karachi, Sindh, Pakistan