Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01659788
First received: August 5, 2012
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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 Intervention
Ovarian Function at Advanced Reproductive Age
Dietary Supplement: Coenzyme Q10 concomitant treatment
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • level of ATP production [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Steriodogenesis associated enzymatic activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovarian Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Embryo quality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • cumulative pregnancy rate per retrieval [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • cumulative live birth rate per retrieval [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Co Enzyme Q10 levels in maternal serum by HPLC [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   38 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659788

Contacts
Contact: Ronit Kochman, MD 00 972 50 8946414 kochman@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lamberg, PhD    00 972 2 677572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ronit Kochman, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01659788     History of Changes
Other Study ID Numbers: CoEnzyme Q10-HMO-CTIL
Study First Received: August 5, 2012
Last Updated: August 7, 2012
Health Authority: Israel: Ministry of Health

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:
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on July 22, 2014