Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
NCT ID: NCT01659788
Last Updated: 2012-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Coenzyme Q10 concomitant treatment
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
Coenzyme Q10 concomitant treatment
Placebo
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.
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Coenzyme Q10 concomitant treatment
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of primary infertility
Exclusion Criteria
* 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.
* 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.
38 Years
43 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hadassah Medical Organization
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronit Kochman, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hadassah Medical Organization
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hadas Lamberg, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CoEnzyme Q10-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id