How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome — CoQ10  

Poor Ovarian Response Clinical Trial

Official title: The Influence of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome in Intrauterine Insemination

Status Terminated

Clinical Trial Summary

As women age the ovarian response and pregnancy rate are reduced while the rate of chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate chromosomal segregation as well as early embryo development and implantation are dependent on the supply of large amounts of energy, which unlike other cells can only arise from the mitochondria. With age the mitochondria becomes less efficient due to damage to its unique DNA, resulting in decreased energy production. The proposed study will examine the effect of the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the ovaries to a medication that stimulates follicle growth. The investigators hypothesize that the improved energetic state of the oocyte would result in a more accurate chromosomal separation, increased embryo quality and pregnancy rate.

Clinical Trial Description

The study will be organized on an outpatient basis at the Toronto Centre for Advanced Reproductive Technology (TCART) and at the Lifequest Centre for Reproductive Medicine. The study will involve 100 women aged 38-43 years.

In the first cycle, study participants will be randomly assigned to either placebo or COQ10 capsules, (AOR - Advanced Orthomolecular Research Inc. 19 St NE Calgary, Alberta, NHPD registration codes 135307 and 113519, respectively). Study participants will take 600 mg of CoQ10 orally or identical placebo capsules for up to 5 cycles if pregnancy does not occur. All subjects will commence controlled ovarian stimulation (COH) using highly purified human menopausal gonadotropins (Menopur; Ferring Inc., North York,Ontario Canada). The starting dosage of Menopur will range from 75IU to 250 IU daily S.C. will be determined by the physician and will begin on the third day of menses, and will continue until the day prior to human chorionic gonadotropin (hCG) administration. The dosage will not be changed and must be maintained for the duration of the study. Menopur will continue daily until follicular development is considered adequate. (at least 1 follicle is >17 mm, and the E2 level is acceptable for the number of follicles present). The patient will receive an injection of hCG 250 mcg (Ovidrel, EMD Serono,Oakville, Ontario, Canada ), SC for the final stage of follicular maturation. Insemination will be by intrauterine insemination (IUI). Luteal support will consist of progesterone suppositiories 200mg (Kingsway Pharmacy,Toronto, Ontario Canada) vaginally per day starting on the day of IUI and will continue for 2 weeks until the serum beta hCG result. At the end of each cycle serum beta hCG will be drawn and if women are pregnant CoQ10/ placebo will be discontinued. If pregnant, luteal support will continue until 10 weeks gestation. If the patient is not pregnant she will have a cycle off COH but may attempt to conceive naturally. In the third cycle, COH using the same dose of Menopur as in the first cycle will be performed with IUI as in cycle one. If not pregnant, another cycle off treatment will be followed by the fifth cycle in which COH and IUI is performed..

The study endpoints will be:

1. Primary outcome measure will be pregnancy rate.

2. Secondary outcome measures will include:

• Peak estradiol level

• The number of follicles > 14 mm on day of hCG

• Number of days of stimulation / units of Menopur needed ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poor Ovarian Response

• NCT number: NCT00878124
• Study type: Interventional
• Source: University of Toronto
• Status: Terminated
• Phase: N/A
• Start date: June 2009