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Completed

NCT Number: NCT04302532

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

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.

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Key information

Conditions

Coenzyme Q10

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aziz medical center

Karachi, Sindh, 74600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10

Drug

antioxidant used to decrease oxidative stress and improve fertility prospects

Other names: celeron sr

Clomiphene Citrate

Drug

ovulation induction drug

Other names: clomid

Primary outcomes

  1. number of ovulating women

    Time frame: 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.

  2. number of pregnancies

    Time frame: 1-2 months

    ultrasound visualization of gestational sac with pulsating fetal pole

Sponsors and collaborators

Lead sponsor

Karachi Medical and Dental College

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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