Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

Hadassah Medical Center

Status: Unknown

Conditions: Ovarian Function at Advanced Reproductive Age

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Coenzyme Q10 concomitant treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01659788

CoEnzyme Q10-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 38 to 43 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Coenzyme Q10 concomitant treatment

Experimental group

Description:

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

Treatment:

Dietary Supplement: Coenzyme Q10 concomitant treatment

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo