Ovarian Function at Advanced Reproductive AgeNCT01659788
Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
A study testing Coenzyme Q10 concomitant treatment in people with Ovarian Function at Advanced Reproductive Age, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval. Read more about this study
- Who is it for?
- Ages 38 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Function at Advanced Reproductive Age
- What is being tested?
- Coenzyme Q10 concomitant treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2014
- 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 38 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 38-43 years at the time of enrollment
- Diagnosis of primary infertility
Who cannot join
- Body mass index (BMI) > 30 kg/m2
- Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
- Any contraindication to being pregnant and carrying a pregnancy to term.
- Contraindication for the use of CoQ10, or fertility medications.
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- Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
- Absence of one or two ovaries
- Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
- History (within past 12 months) or current abuse of alcohol or drugs.
- Administration of any investigational drugs within three months prior to study enrollment.
- Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
- Unexplained gynecological bleeding.
- Ejaculated sperm is not sufficient for ICSI
- Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
- Abnormal COH screening blood done for both partners, including: prolactin, thyroid stimulating hormone, HIV serology, Hepatitis B and C serology, Rubella, group and screen and syphilis serology prior to participation in study.
- Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
- The concurrent use of any of the following drugs:
- Daunorubicin, Doxorubicin, Blood Pressure Medications, Warfarin, Timolol, atorvastatin, cerivastatin, lovastatin, pravastatin, simvastatin gemfibrozil, tricyclic antidepressant medications (including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine) multivitamins or any vitamin supplementation except Folic acid.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Hadas Lamberg, PhD, 00 972 2 677572, lhadas@hadassah.org.il
About this study
The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval.
- Being tested
- Coenzyme Q10 concomitant treatment, Placebo
- Keywords
- Advanced Reproductive Age, poor ovarian response, Mitochondrial dysfunction, Mitochondrial nutrients, Coenzyme Q10, Electron transfer chain
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 concomitant treatmentDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 concomitant treatment | Experimental | Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment
Dose: 600 mg by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the CoEnzyme Q10 if conceives or when the study is completed.
Other name: Ubiquinone Receives: Dietary Supplement: Coenzyme Q10 concomitant treatment |
| Placebo | Placebo comparator | 1 capsule by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the placebo when she conceives or when the study is completed. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of ATP production
Measured: 2 years
Steriodogenesis associated enzymatic activity
Measured: 2 years
Secondary outcomes (4)
Ovarian Response
Measured: 2 years
Embryo quality
Measured: 2 years
cumulative pregnancy rate per retrieval
Measured: 2 years
cumulative live birth rate per retrieval
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Function at Advanced Reproductive AgeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronit Kochman, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659788
- Sponsor's protocol ID
- CoEnzyme Q10-HMO-CTIL
- Status last verified
- Aug 2012
- First submitted
- 5 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
- ClinicalTrials.gov ID
- NCT01659788
- Acronym / sponsor ID
- CoEnzyme Q10-HMO-CTIL
- Keywords
- Advanced Reproductive Age, poor ovarian response, Mitochondrial dysfunction, Mitochondrial nutrients, Coenzyme Q10, Electron transfer chain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 8 Aug 2012 (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.
The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 concomitant treatment | Experimental | Dietary Supplement: Coenzyme Q10 concomitant treatmentCoenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment Dose: 600 mg by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the CoEnzyme Q10 if conceives or when the study is completed. Other name: Ubiquinone |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the placebo when she conceives or when the study is completed. |
Who may qualify
- Ages
- 38 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 38-43 years at the time of enrollment
- Diagnosis of primary infertility
Key exclusion criteria (19 listed)
- Body mass index (BMI) > 30 kg/m2
- Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
- Any contraindication to being pregnant and carrying a pregnancy to term.
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 Q10 concomitant treatment | Dietary supplement | Coenzyme Q10 concomitant treatment |
| Placebo | Dietary supplement | Placebo |
Primary outcome
level of ATP production
Time frame: 2 years
Steriodogenesis associated enzymatic activity
Time frame: 2 years
4 secondary outcomes
Ovarian Response
Time frame: 2 years
Embryo quality
Time frame: 2 years
cumulative pregnancy rate per retrieval
Time frame: 2 years
cumulative live birth rate per retrieval
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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.
Ronit Kochman, MD principal investigator
Hadassah Medical Organization
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 concomitant treatment in people with Ovarian Function at Advanced Reproductive Age, run by Hadassah Medical Organization at 1 site in Israel.
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 19 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: status not confirmed, as of the sponsor's last update on 8 Aug 2012. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Kochman, MD (00 972 50 8946414, kochman@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of ATP production (time frame: 2 years). 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 8 Aug 2012.