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Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659788
Recruitment Status : Unknown
Verified August 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Function at Advanced Reproductive Age Dietary Supplement: Coenzyme Q10 concomitant treatment Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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

Dietary Supplement: Coenzyme Q10 concomitant treatment
Placebo Comparator: 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.
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. level of ATP production [ Time Frame: 2 years ]
  2. Steriodogenesis associated enzymatic activity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Ovarian Response [ Time Frame: 2 years ]
  2. Embryo quality [ Time Frame: 2 years ]
  3. cumulative pregnancy rate per retrieval [ Time Frame: 2 years ]
  4. cumulative live birth rate per retrieval [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Co Enzyme Q10 levels in maternal serum by HPLC [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 38-43 years at the time of enrollment
  • Diagnosis of primary infertility

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659788

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Contact: Ronit Kochman, MD 00 972 50 8946414

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Hadassah Medical Organization
Jerusalem, Israel
Contact: Hadas Lamberg, PhD    00 972 2 677572   
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Ronit Kochman, MD Hadassah Medical Organization

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Responsible Party: Hadassah Medical Organization Identifier: NCT01659788    
Other Study ID Numbers: CoEnzyme Q10-HMO-CTIL
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Keywords provided by Hadassah Medical Organization:
Advanced Reproductive Age
poor ovarian response
Mitochondrial dysfunction
Mitochondrial nutrients
Coenzyme Q10
Electron transfer chain
Additional relevant MeSH terms:
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Coenzyme Q10
Growth Substances
Physiological Effects of Drugs