Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

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 Overview

• Status: Unknown
• Conditions: Ovarian Function at Advanced Reproductive Age
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Coenzyme Q10 concomitant treatment

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronit Kochman, MD; Phone Number: 00 972 50 8946414; Email: kochman@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization
    • Contact: Hadas Lamberg, PhD; Phone Number: 00 972 2 677572; Email: lhadas@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 43 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
level of ATP production	2 years
Steriodogenesis associated enzymatic activity	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Embryo quality	2 years
Ovarian Response	2 years
cumulative pregnancy rate per retrieval	2 years
cumulative live birth rate per retrieval	2 years

Other Outcome Measures

Outcome Measure	Time Frame
Co Enzyme Q10 levels in maternal serum by HPLC	2 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: August 5, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (ESTIMATE): August 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2012
• Last Update Submitted That Met QC Criteria: August 7, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Mitochondrial dysfunction; Mitochondrial nutrients; Coenzyme Q10; Electron transfer chain; poor ovarian response; Advanced Reproductive Age
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: CoEnzyme Q10-HMO-CTIL