Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS
Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedNovember 25, 2020
November 1, 2020
3 months
March 6, 2020
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
number of pregnancies
ultrasound visualization of gestational sac with pulsating fetal pole
1-2 months
Study Arms (2)
Clomiphene
ACTIVE COMPARATORclomiphene citrate 150 mg once a day for 5 days
clomiphene and coenzyme q10
EXPERIMENTALclomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
Interventions
antioxidant used to decrease oxidative stress and improve fertility prospects
ovulation induction drug
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aziz medical center
Karachi, Sindh, 74600, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rubina Izhar
Aziz Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical investigator
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 10, 2020
Study Start
July 1, 2020
Primary Completion
September 30, 2020
Study Completion
October 30, 2020
Last Updated
November 25, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share