The Effect of Co Enzyme Q10 Together With Fertility Drugs on Pregnancy Outcome of in Vitro Fertilization

NCT01048385 | Terminated

• 1 other identifier: CoQ10-IVF
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of our research is to increase live birth rates in infertile women and to reduce the incidence of aneuploidy leading to miscarriage and trisomies. We hypothesize that an age related mitochondrial dysfunction reduces the availability of energy in the oocyte and contributes to abnormal segregation of chromosomes during the meiotic division leading to oocyte aneuploidy. Based on preliminary evidence we have obtained in aged mice, we propose that dietary supplementation with Co enzyme Q10 in older women will improve mitochondrial function in the oocytes, leading to a decrease in chromosomal non-disjunction and resulting in embryos with a normal chromosomal complement. Our primary outcome measure will be determination of oocyte chromosome number by multiplex PCR based assay of polar bodies biopsied at the time of IVF. Outcomes of this proposal will enable us to address the mechanisms of ovarian aging and may explain etiology of decreased fertility in older patients. In addition, our work will add to the feasibility of single embryo transfer, thereby avoiding multiple pregnancies and their associated cost to the health care system and to society.

Conditions

Aneuploidy; Pregnancy; Miscarriage

Keywords

Mitochondrial dysfunction; Mitochondrial nutrients; Aneuploidy; Meiotic Spindle; Coenzyme Q10; Electron transfer chain

Outcome Measures

Primary Outcomes (1)

• Number and percentage of euploid eggs per retrieval

  1 year

Secondary Outcomes (5)

• Ovarian response

  2 years

• Embryo quality

  2 years

• Cumulative pregnancy rate/retrieval

  2 years

• Cumulative live birth rate/retrieval

  2 years

• CoQ10 activity in saliva and follicular fluid by arNOX assay

  2 years

Study Arms (2)

CoQ10

EXPERIMENTAL

This group will be treated concomitantly with Coenzyme Q10

Dietary Supplement: Coenzyme Q10 concomitant treatment

Control

PLACEBO COMPARATOR

Treated with capsules containing the vehicle.

Dietary Supplement: Placebo

Interventions

Coenzyme Q10 concomitant treatment DIETARY_SUPPLEMENT

Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment

Also known as: Many different brands

CoQ10

Placebo DIETARY_SUPPLEMENT

Treated with capsules containing the vehicle (Sesame oil).

Control

Eligibility Criteria

• Age: 35 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-43 years at the time of enrollment
• Diagnosis of primary infertility

You may not qualify if:

• Body mass index (BMI) \> 38 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, Superfact, Puregon, hCG, Estrace and Progesterone suppositories.
• 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.

Sponsors & Collaborators

• University of Toronto: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

The Toronto Center for Advanced Reproductive Technology

Toronto, Ontario, M5S 2X9, Canada

Location

Related Publications (1)

• Bentov Y, Esfandiari N, Burstein E, Casper RF. The use of mitochondrial nutrients to improve the outcome of infertility treatment in older patients. Fertil Steril. 2010 Jan;93(1):272-5. doi: 10.1016/j.fertnstert.2009.07.988. Epub 2009 Sep 3.

  PMID: 19732879 BACKGROUND

MeSH Terms

Conditions

Aneuploidy; Abortion, Spontaneous; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert F Casper, Dr.

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

CA (1)