Polycystic Ovary SyndromeNCT01910766
Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome
A study testing Coenzyme Q10 and clomiphene citrate in people with Polycystic Ovary Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Coenzyme Q10 and clomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of 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
- patients with hyperprolactinaemia,
- hypercorticism and
- thyroid dysfunction.
- patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.
Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.
Read the detailed description
No more details
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Coenzyme Q10, clomiphene citrate
- Keywords
- pcos, coenzymeQ10, clomiphene citrate
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCG
no more details
clomiphene citrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10/CC group | Experimental | Intervention:
Coenzyme Q10 (CoQ10) and clomiphene citrate group (55 patients, 82 cycles) Patients in CoQ10/CC group took CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6, and CoQ10 Mepaco, Enshas Elraml, Sharkhia, Egypt), in a dose of 60 mg 3 times day capsules orally starting on cycle day 2 and continued till the day of human chorionic gonadotropin (hCG) administration Receives: Drug: Coenzyme Q10; Drug: clomiphene citrate |
| CC alone group | Active comparator | Intervention:
CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6 Receives: Drug: clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ovulating patients
Measured: 1-2 months
Secondary outcomes (1)
Number of pregnancies
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 posted30 Jul 2013 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed M. badawy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910766
- Sponsor's protocol ID
- CoQ10
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
El Refaeey A, Selem A, Badawy A. Combined coenzyme Q10 and clomiphene citrate for ovulation induction in clomiphene-citrate-resistant polycystic ovary syndrome. Reprod Biomed Online. 2014 Jul;29(1):119-24. doi: 10.1016/j.rbmo.2014.03.011. Epub 2014 Mar 26.
PubMed 24813752
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01910766
- Acronym / sponsor ID
- CoQ10
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- pcos, coenzymeQ10, clomiphene citrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jul 2013 (estimated)
- 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.
Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.
Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.
Detailed description
No more details
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10/CC group | Experimental | Drug: Coenzyme Q10, Drug: clomiphene citrateIntervention: Coenzyme Q10 (CoQ10) and clomiphene citrate group (55 patients, 82 cycles) Patients in CoQ10/CC group took CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6, and CoQ10 Mepaco, Enshas Elraml, Sharkhia, Egypt), in a dose of 60 mg 3 times day capsules orally starting on cycle day 2 and continued till the day of human chorionic gonadotropin (hCG) administration |
| CC alone group | Active comparator | Drug: clomiphene citrateIntervention: CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of 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 (4 listed)
- patients with hyperprolactinaemia,
- hypercorticism and
- thyroid dysfunction.
- patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants
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: CC 100 mg/day 2-6 and CoQ10,60 mg 3 times day orally on day 2 till hCGno more details | Drug | Coenzyme Q10/CC group |
| clomiphene citrate | Drug | CC alone group, Coenzyme Q10/CC group |
Primary outcome
Number of ovulating patients
Time frame: 1-2 months
1 secondary outcome
Number of pregnancies
Time frame: 1-2 months
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 30 Jul 2013.
- Derived from this study: PubMed 24813752El Refaeey A, Selem A, Badawy A. Combined coenzyme Q10 and clomiphene citrate for ovulation induction in clomiphene-citrate-resistant polycystic ovary syndrome. Reprod Biomed Online. 2014 Jul;29(1):119-24. doi: 10.1016/j.rbmo.2014.03.011. Epub 2014 Mar 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 and clomiphene citrate in people with Polycystic Ovary Syndrome, run by Mansoura University at 1 site in Egypt.
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 4 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 30 Jul 2013. 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 Egypt. 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.
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 patients (time frame: 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910766, which also lists 1 linked publication.
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 30 Jul 2013.