Objective: to determine the effect of adding Co-Q10 on the implantation and pregnancy in ART cycles
Study design:This randomized study medication Co- Q10, phase two trials, single-center, will be carried out.
Population of the study: This study infertility patients undergoing IVF or ICSI, will be carried out until a sufficient number of cases to 64 cases will continue.
Main inclusion criteria: women with ages between 20 and 42 years who have a large number of fresh embryos are transferred.
Main exclusion criteria: factors related to patients, such as women over 42 years, patients with underlying conditions such as gastrointestinal disorders, gynecological diseases such as endometriosis.
Intervention:The case group will be prescribed medication Co-Q10.
Intervention time: one year
Main outcome measures variables: 64 women about to undergo ICSI be the starting gonadotropin enzyme Co-Q10 is also in the vicinity of a daily routine treatment protocols will be given to them after the ultrasound monitoring of follicular development and testing serum hormone was confirmed by IVF or ICSI to puncture the ovaries and the eggs are recovered and the number of eggs, number of embryos and the embryos and the fertilization qualities and Implantation will be recorded and pregnancy by measuring serum BHCG be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102724746N1
Registration date:2015-12-13, 1394/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-13, 1394/09/22
Registrant information
Name
Samira Abdollahi Moghaddam Foumani
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 8229
Email address
abdollahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center,Vice chancellor for research, Tabriz University of Medic
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Q10 co-enzyme effect on fetus implantation in ART cycles in infertile persons
Public title
Q10 co-enzyme effect on fetus implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; women with ages between 20 and 42 years who have a high number of embryos transferred are fresh.(The maximum number of embryos transferred in the order of 2 to 3 cycles of ovulation induction (Fresh Embryo)). Exclusion criteria; associated with individual factors such as women over 42 years; the number of embryos down; diseases such as patients with gastrointestinal disorders; patients with liver disorders; gynecological factors like endometriosis; genital anomalies such as disorders of the fallopian tube; uterine anatomic abnormalities.
Age
From 20 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Golgasht avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5165665931
Approval date
2015-10-10, 1394/07/18
Ethics committee reference number
tbzmed.rec.1394.583
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Embryo Quality
Timepoint
monthly after drug Prescription
Method of measurement
evaluation of pregnancy with B-HCG test at the end of drug use
2
Description
Embryo
Timepoint
monthly after drug Prescription
Method of measurement
evaluation of pregnancy with B-HCG test at the end of drug use
3
Description
Ovule
Timepoint
monthly after drug Prescription
Method of measurement
evaluation of pregnancy with B-HCG test at the end of drug use
Secondary outcomes
1
Description
pregnancy ratio
Timepoint
monthly
Method of measurement
pregnancy lab test (B-HCG)
Intervention groups
1
Description
In this study,intervention group will be prescribed the drug Q10 to implantation of the embryo after administration of the study.
Category
Treatment - Drugs
2
Description
The control group will be given medicines to evaluate the implantation of the embryo in the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility ward, Alzahra Hospital
Full name of responsible person
Dr Samira Abdollahi
Street address
Baghshomal Square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Health Research Center,Vice chancellor for research, Tabriz University of Medic
Full name of responsible person
Mrs Lahroudi
Street address
Alzahra Hospital, Baghshomal Square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center,Vice chancellor for research, Tabriz University of Medic
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Samira Abdollahi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Alzahra Hospital, Baghshomal Square
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
+98 41 3330 8229
Email
abdollahis@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Dr Samira Abdollahi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Alzahra Hospital, Baghshomal Square
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
+98 41 3330 8229
Email
abdollahis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samira Abdollahi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Alzahra Hospital, Baghshomal Square
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
+98 41 3330 8229
Email
abdollahis@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)