How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome (CoQ10)
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|ClinicalTrials.gov Identifier: NCT00878124|
Recruitment Status : Terminated (Very low recruitment rate)
First Posted : April 8, 2009
Last Update Posted : January 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Poor Ovarian Response||Dietary Supplement: Coenzyme Q10 co treatment Other: Placebo Caps||Not Applicable|
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:
- Primary outcome measure will be pregnancy rate.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Influence of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome in Intrauterine Insemination|
|Study Start Date :||June 2009|
Coenzyme Q10 co-treatment
Dietary Supplement: Coenzyme Q10 co treatment
CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study.
Other Name: Ubiquinone.
Placebo Comparator: Placebo control
Other: Placebo Caps
3 caps twice a day continuously until pregnant or at the end of the study.
- Pregnancy rate [ Time Frame: Every cycle ]
- Peak estradiol level [ Time Frame: Every cycle ]
- The number of follicles > 14 mm on day of hCG [ Time Frame: Every cycle ]
- Number of days of stimulation/units of Menopur needed [ Time Frame: Every cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878124
|LifeQuest Centre for Reproductive Medicine|
|Toronto, Ontario, Canada, M5G 2K4|
|Toronto center for advanced reprodutive technology|
|Toronto, Ontario, Canada, M5S 2X9|
|Principal Investigator:||Robert F Casper, Prof||University of Toronto|