Poor Ovarian ResponseCoQ10NCT00878124
How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome
A study testing Coenzyme Q10 co treatment in people with Poor Ovarian Response, run by University of Toronto at 2 sites in Canada.
Trial summary
As women age the ovarian response and pregnancy rate are reduced while the rate of chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate chromosomal segregation as well as early embryo development and implantation are dependent on the supply of large amounts of energy, which unlike other… 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
- Poor Ovarian Response
- What is being tested?
- Coenzyme Q10 co treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2009to not given
- 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
- Each patient must meet the following criteria:
- Age 38-43 years at the time of enrollment
- Diagnosis of primary infertility
Who cannot join
- Patients must NOT have any of the following:
- Body mass index (BMI) > 38 kg/m2
- Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.
- Abnormal uterine cavity and /or tubal blockage as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication within 3 months of study enrollment.
- Any contraindication to being pregnant and carrying a pregnancy to term.
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- Contraindication for the use of CoQ10, Menopur, hCG, and Prometrium.
- Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
- Absence of one ovary
- Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, 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.
- Abnormal sperm quality or semen sample inadequate for IUI preparation (TMC > 1x106 post wash)
- Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
- Abnormal COH screening bloods for either partner, including: HIV serology, Hepatitis B and C serology, Rubella, and syphilis serology prior to participation in study.
- Unwillingness to give written informed consent.
- The concurrent use of any of the following drugs:
- CoQ10: 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).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
LifeQuest Centre for Reproductive Medicine
Toronto, Ontario, M5G 2K4
Toronto center for advanced reprodutive technology
Toronto, Ontario, M5S 2X9
About this study
Official title: The Influence of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome in Intrauterine Insemination
As women age the ovarian response and pregnancy rate are reduced while the rate of chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate chromosomal segregation as well as early embryo development and implantation are dependent on the supply of large amounts of energy, which unlike other cells can only arise from the mitochondria. With age the mitochondria becomes less efficient due to damage to its unique DNA, resulting in decreased energy production. The proposed study will examine the effect of the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the ovaries to a medication that stimulates follicle growth. The investigators hypothesize that the improved energetic state of the oocyte would result in a more accurate chromosomal separation, increased embryo quality and pregnancy rate.
Read the detailed description
The study will be organized on an outpatient basis at the Toronto Centre for Advanced Reproductive Technology (TCART) and at the Lifequest Centre for Reproductive Medicine. The study will involve 100 women aged 38-43 years.
In the first cycle, study participants will be randomly assigned to either placebo or COQ10 capsules, (AOR - Advanced Orthomolecular Research Inc. 19 St NE Calgary, Alberta, NHPD registration codes 135307 and 113519, respectively). Study participants will take 600 mg of CoQ10 orally or identical placebo capsules for up to 5 cycles if pregnancy does not occur. All subjects will commence controlled ovarian stimulation (COH) using highly purified human menopausal gonadotropins (Menopur; Ferring Inc., North York,Ontario Canada). The starting dosage of Menopur will range from 75IU to 250 IU daily S.C. will be determined by the physician and will begin on the third day of menses, and will continue until the day prior to human chorionic gonadotropin (hCG) administration. The dosage will not be changed and must be maintained for the duration of the study. Menopur will continue daily until follicular development is considered adequate. (at least 1 follicle is >17 mm, and the E2 level is acceptable for the number of follicles present). The patient will receive an injection of hCG 250 mcg (Ovidrel, EMD Serono,Oakville, Ontario, Canada ), SC for the final stage of follicular maturation. Insemination will be by intrauterine insemination (IUI). Luteal support will consist of progesterone suppositiories 200mg (Kingsway Pharmacy,Toronto, Ontario Canada) vaginally per day starting on the day of IUI and will continue for 2 weeks until the serum beta hCG result. At the end of each cycle serum beta hCG will be drawn and if women are pregnant CoQ10/ placebo will be discontinued. If pregnant, luteal support will continue until 10 weeks gestation. If the patient is not pregnant she will have a cycle off COH but may attempt to conceive naturally. In the third cycle, COH using the same dose of Menopur as in the first cycle will be performed with IUI as in cycle one. If not pregnant, another cycle off treatment will be followed by the fifth cycle in which COH and IUI is performed..
The study endpoints will be:
- Primary outcome measure will be pregnancy rate.
- Secondary outcome measures will include:
- Peak estradiol level
- The number of follicles > 14 mm on day of hCG
- Number of days of stimulation / units of Menopur needed
- Conditions
- Poor Ovarian Response
- Being tested
- Coenzyme Q10 co treatment, Placebo Caps
- Keywords
- Poor ovarian response, Chromosomal aberrations, poor pregnancy outcome, Late maternal age
- Medical subject headings
- Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 co treatmentDietary supplement
Also called Ubiquinone.
CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study.
Placebo CapsOther
3 caps twice a day continuously until pregnant or at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| CoQ10 | Experimental | Coenzyme Q10 co-treatment Receives: Dietary Supplement: Coenzyme Q10 co treatment |
| Placebo control | Placebo comparator | Placebo Co-treatment Receives: Other: Placebo Caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: Every cycle
Secondary outcomes (3)
Peak estradiol level
Measured: Every cycle
The number of follicles > 14 mm on day of hCG
Measured: Every cycle
Number of days of stimulation/units of Menopur needed
Measured: Every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startJun 2009
Why it stopped: Very low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Centre for Advanced Reproductive Technology, Ferring Pharmaceuticals
- Investigators
- Robert F Casper, Prof, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878124
- Sponsor's protocol ID
- CoQ10 - 08-0205-A
- Acronym
- CoQ10
- Status last verified
- Jan 2010
- First submitted
- 7 Apr 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome in Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT00878124
- Acronym / sponsor ID
- CoQ10 / CoQ10 - 08-0205-A
- Conditions
- Poor Ovarian Response
- Keywords
- Poor ovarian response, Chromosomal aberrations, poor pregnancy outcome, Late maternal age
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low recruitment rate
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Toronto Centre for Advanced Reproductive Technology, Ferring Pharmaceuticals
- Study start
- Jun 2009
- First posted
- 8 Apr 2009 (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.
As women age the ovarian response and pregnancy rate are reduced while the rate of chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate chromosomal segregation as well as early embryo development and implantation are dependent on the supply of large amounts of energy, which unlike other cells can only arise from the mitochondria. With age the mitochondria becomes less efficient due to damage to its unique DNA, resulting in decreased energy production. The proposed study will examine the effect of the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the ovaries to a medication that stimulates follicle growth. The investigators hypothesize that the improved energetic state of the oocyte would result in a more accurate chromosomal separation, increased embryo quality and pregnancy rate.
Detailed description
The study will be organized on an outpatient basis at the Toronto Centre for Advanced Reproductive Technology (TCART) and at the Lifequest Centre for Reproductive Medicine. The study will involve 100 women aged 38-43 years.
In the first cycle, study participants will be randomly assigned to either placebo or COQ10 capsules, (AOR - Advanced Orthomolecular Research Inc. 19 St NE Calgary, Alberta, NHPD registration codes 135307 and 113519, respectively). Study participants will take 600 mg of CoQ10 orally or identical placebo capsules for up to 5 cycles if pregnancy does not occur. All subjects will commence controlled ovarian stimulation (COH) using highly purified human menopausal gonadotropins (Menopur; Ferring Inc., North York,Ontario Canada). The starting dosage of Menopur will range from 75IU to 250 IU daily S.C. will be determined by the physician and will begin on the third day of menses, and will continue until the day prior to human chorionic gonadotropin (hCG) administration. The dosage will not be changed and must be maintained for the duration of the study. Menopur will continue daily until follicular development is considered adequate. (at least 1 follicle is >17 mm, and the E2 level is acceptable for the number of follicles present). The patient will receive an injection of hCG 250 mcg (Ovidrel, EMD Serono,Oakville, Ontario, Canada ), SC for the final stage of follicular maturation. Insemination will be by intrauterine insemination (IUI). Luteal support will consist of progesterone suppositiories 200mg (Kingsway Pharmacy,Toronto, Ontario Canada) vaginally per day starting on the day of IUI and will continue for 2 weeks until the serum beta hCG result. At the end of each cycle serum beta hCG will be drawn and if women are pregnant CoQ10/ placebo will be discontinued. If pregnant, luteal support will continue until 10 weeks gestation. If the patient is not pregnant she will have a cycle off COH but may attempt to conceive naturally. In the third cycle, COH using the same dose of Menopur as in the first cycle will be performed with IUI as in cycle one. If not pregnant, another cycle off treatment will be followed by the fifth cycle in which COH and IUI is performed..
The study endpoints will be:
- Primary outcome measure will be pregnancy rate.
- Secondary outcome measures will include:
- Peak estradiol level
- The number of follicles > 14 mm on day of hCG
- Number of days of stimulation / units of Menopur needed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQ10 | Experimental | Dietary Supplement: Coenzyme Q10 co treatmentCoenzyme Q10 co-treatment |
| Placebo control | Placebo comparator | Other: Placebo CapsPlacebo Co-treatment |
Who may qualify
- Ages
- 38 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Each patient must meet the following criteria:
- Age 38-43 years at the time of enrollment
- Diagnosis of primary infertility
Key exclusion criteria (20 listed)
- Patients must NOT have any of the following:
- Body mass index (BMI) > 38 kg/m2
- Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.
- Abnormal uterine cavity and /or tubal blockage as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication within 3 months of study enrollment.
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 co treatmentAlso: Ubiquinone.CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study. | Dietary supplement | CoQ10 |
| Placebo Caps3 caps twice a day continuously until pregnant or at the end of the study. | Other | Placebo control |
Primary outcome
Pregnancy rate
Time frame: Every cycle
3 secondary outcomes
Peak estradiol level
Time frame: Every cycle
The number of follicles > 14 mm on day of hCG
Time frame: Every cycle
Number of days of stimulation/units of Menopur needed
Time frame: Every cycle
Results and safety
The study was stopped early (reason given: Very low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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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.
Robert F Casper, Prof principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 co treatment in people with Poor Ovarian Response, run by University of Toronto at 2 sites in Canada.
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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study was stopped early (reason given: Very low recruitment rate). Results are not available in the source record.
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?
Pregnancy rate (time frame: Every cycle). 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 12 Jan 2010.