Coenzyme q10Phase 4NCT04302532
Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS
A Phase 4 study testing Coenzyme Q10 and clomiphene citrate in people with Coenzyme q10, run by Karachi Medical and Dental College at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Coenzyme q10
- What is being tested?
- Coenzyme Q10 and clomiphene citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome
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
- Coenzyme q10
- Being tested
- Coenzyme Q10, clomiphene citrate
- Keywords
- ovulation induction, coenzyme q10, pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called celeron sr
antioxidant used to decrease oxidative stress and improve fertility prospects
clomiphene citrateDrug
Also called clomid
ovulation induction drug
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene | Active comparator | clomiphene citrate 150 mg once a day for 5 days Receives: Drug: clomiphene citrate |
| clomiphene and coenzyme q10 | Experimental | clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day Receives: Drug: Coenzyme Q10; Drug: clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 months
number of pregnancies
ultrasound visualization of gestational sac with pulsating fetal pole
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coenzyme q10Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karachi Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samia husain, Karachi Medical and Dental College
- Investigators
- Rubina Izhar, Study director, Aziz Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302532
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04302532
- Acronym / sponsor ID
- 1
- Conditions
- Coenzyme q10
- Keywords
- ovulation induction, coenzyme q10, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Karachi Medical and Dental CollegeUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene | Active comparator | Drug: clomiphene citrateclomiphene citrate 150 mg once a day for 5 days |
| clomiphene and coenzyme q10 | Experimental | Drug: Coenzyme Q10, Drug: clomiphene citrateclomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: celeron srantioxidant used to decrease oxidative stress and improve fertility prospects | Drug | clomiphene and coenzyme q10 |
| clomiphene citrateAlso: clomidovulation induction drug | Drug | Clomiphene, clomiphene and coenzyme q10 |
Primary outcome
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.
number of pregnancies
Time frame: 1-2 months
ultrasound visualization of gestational sac with pulsating fetal pole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
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Metabolic Effects of an Ophiocordyceps Sinensis- and CoQ10-Based Formulation in Mild-to-Moderate Hypercholesterolemia
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COQ10 and Vitamin E for Off-Target Radiation Toxicity
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The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubina Izhar study director
Aziz Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 and clomiphene citrate in people with Coenzyme q10, run by Karachi Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of ovulating women (time frame: 1-2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.