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

Coenzyme q10 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302532
• Other study ID #: 1
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Karachi Medical and Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Coenzyme q10

Intervention

Drug:
• Coenzyme Q10
antioxidant used to decrease oxidative stress and improve fertility prospects
• clomiphene citrate
ovulation induction drug

Locations

Country	Name	City	State
Pakistan	Aziz medical center	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Karachi Medical and Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of ovulating women	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
Primary	number of pregnancies	ultrasound visualization of gestational sac with pulsating fetal pole	1-2 months