CompletedNCT04302532Updated Nov 25, 2020

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

A Phase 4 interventional study of Coenzyme Q10 and clomiphene citrate in Coenzyme q10, sponsored by Karachi Medical and Dental College. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Karachi Medical and Dental College · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 149
Allocation: Randomized
Ages: 20 Years to 35 Years
Sex: Female

Study 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.

Conditions studied

Coenzyme q10

Keywords

ovulation induction
coenzyme q10
pregnancy rate

In context

Lead sponsor

Karachi Medical and Dental College is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 35 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 149 participants (actual)

Study arms

Active comparator
Clomiphene
clomiphene citrate 150 mg once a day for 5 days
Drug: clomiphene citrate
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 · Drug: clomiphene citrate

Interventions

DrugCoenzyme Q10
antioxidant used to decrease oxidative stress and improve fertility prospects
Also known as: celeron sr
Drugclomiphene citrate
ovulation induction drug
Also known as: clomid

What researchers measure

Primary outcomes

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.
Time frame: 1-2 months
number of pregnancies
ultrasound visualization of gestational sac with pulsating fetal pole
Time frame: 1-2 months

Study locations

1 site

Aziz medical center
Karachi, Sindh 74600, Pakistan

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04302532
Lead sponsor: Karachi Medical and Dental College
Responsible party: samia husain (clinical investigator, Karachi Medical and Dental College) — Principal investigator
First posted: Mar 10, 2020
Start date: Jul 1, 2020
Primary completion: Sep 30, 2020
Completion: Oct 30, 2020
Last update: Nov 25, 2020

Study contacts

Rubina Izhar

study director · Aziz Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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