This study investigates the impact of using coenzyme Q10 in fertility outcome in "in vitro" fertilization ways. Patients include 30 women with poor ovarian response will be undergoing FLARE protocol who will be refered to Fatemieh hospital. The patients are divided into two equal groups randomly treated with Q10 and control group.
Treatment group members receive 200 mg Q10 daily ,eight weeks prior to ovulation induction and during performing IVF,in total ,for 3 months and control group receive placebo.
During the first two month serum level of LH, FSH and estradiol are measured monthly. At the same time 1 month before undergoing IVF patients will receive OCP daily from day 3 of period. And second day of next month period, LH, FSH and estradiol are measured . and two 0/1 mg Decapeptid Ampule are injected one per day and from the third day on ,Gonadotropine injection with 300-450 IU dose is started and every 3-4 days, trans-vaginal sonography is conducted until the size of the follicle equals 18mm .Then 10000 units of HCG ampule is injection to the patient and 36 hours later ,the processed sperm micro injection is conducted and 48-72 hours later , the transfer is accomplished and two weeks later, BHCG test is conducted in the laboratory of Fatemieh hospital .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092810958N1
Registration date:2014-07-10, 1393/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-10, 1393/04/19
Registrant information
Name
Zhila Golmohammadi
Name of organization / entity
Hamedan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
zh.golmohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 in invitro fertilization results (IVF) in infertile women with poor ovarian response
Public title
Effects of coenzyme Q10 in female infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion caricteria:primary infertility; age over 35 years; FSH>10 on the third day of the cycle; ovarian volume<3ml; oocyte<3-5
Exclusion caricteria:Lack of consent to the continuation of the treatment;Not referring the patient to continue treatment at designated times; any current use of systemic steroid medication within 3 months of study enrollment; any contraindication to being pregnant and carrying a pregnancy to term; absence of one ovary; clinically relevant chronic systemic disease(diabet -HTN) and malagnancies; use of insuline ,beta blocker,TCA,Estatine,comadine,warfarine,phenazopridine
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Mhdiye Blvd
City
Hamedan
Postal code
3519638686
Approval date
2012-07-03, 1391/04/13
Ethics committee reference number
/16/35/9/1216 /د/پ
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Inability to achieve a pregnancy
Primary outcomes
1
Description
Pregnancy Rate
Timepoint
Every Cycle
Method of measurement
Pregnancy Test(BHCG)
Secondary outcomes
1
Description
Number of days induction
Timepoint
Daily
Method of measurement
Counting the days
2
Description
Number of gonadotropin ampules induction
Timepoint
Daily
Method of measurement
Counting ampoules
Intervention groups
1
Description
Intervention group:Patients receive 200 mg of coenzyme Q10 from 8 weeks before stimulates the egg agency to three months after .
Category
Treatment - Drugs
2
Description
Control group:Patients recieve placebo 8 weeks before stimulates the egg agency to three months after.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Marzieh Farimani
Street address
Fatemieh Hospital, Pasdaran avenue
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan Univesity of Medical Sciences
Full name of responsible person
Heydar Tavillani
Street address
Mahdiye Blvd, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan Univesity of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Zhila Golmohammadi
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran avenue, Hamadan
City
Hamadan
Postal code
3519638686
Phone
+98 81 1837 1531
Fax
+98 81 1828 3939
Email
www.Zh.golmohammadi@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Marzieh Farimani
Position
Obstetric and Gynecology Surgeon
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran avenue
City
Hamadan
Postal code
3519638686
Phone
+98 81 1827 7011
Fax
+98 81 1827 7012
Email
M.faremani@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zhila Golmohammadi
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran avenue
City
Hamadan
Postal code
00988118371531
Phone
+98 81 1837 1531
Fax
+98 81 1828 3939
Email
www.zh.golmohammadi@umsha.ac.ir
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)