The effects of testosterone gel administration in the ovarian response to FSH in older women with poor response to traditional methods of assisted reproduction
In this study, 64 infertile women with inclusion criteria were selected and randomly divided into intervention and control groups.Participants divided into two groups of 32 people in two consecutive cycles (first cycle: Cycle Control CC, second cycle: treatment cycle TC) are examined.Hormones and sonographic evaluations are monitored.10,000 micro-units of HCG urine when at least three follicles have reached a diameter of 17 mm, both cycle and in both prescribed and administered for luteal phase progesterone support is 200 mg twice a day. Within 15 to 20 days by administration of a GnRH agonist to suppress pituitary and ovarian stimulation for IVF and ICSI is the second period, the rate of 1 mg daily testosterone gel 1% (10 mg) in the thigh and the outer surface The control group used a placebo gel.Time ultrasound within 2 to 4 days before the last administration of prescription gels and gel, and the FSH day to HCG day administration is prescribed.Hormones that are measured include E2, FSH, LH and progesterone are hormones by ECLIA done and measurement time of 2 to 4 days and on the last day of each cycle is administered gel.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505197513N11
Registration date:2015-05-29, 1394/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-29, 1394/03/08
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
esfahan University of medical scinces -Vice Chancellor for Research
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of testosterone gel administration in the ovarian response to FSH in older women with poor response to traditional methods of assisted reproduction
Public title
The effects of testosterone gel administration in ART
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-aged between 30 and 42 years
2-agreed to participate in the study
3- poor response to ovarian stimulation in IVF and ICSI methods previous (plasma estradiol level <1200 pg ml daily on HCG, the number of oocytes <5)
4- evidence of decreased ovarian reserve (which Drsvmyn day menstrual cycle, according to an abnormally low level of estradiol, inhibin B, and FSH defined)
5- no history of ovarian surgery, endometriosis, metabolic disorders and cancer Brest
Exclusion criteria:
1- not referring patients to determine the level of hormones in ovarian reserves
2- lack of testosterone gel completely or irregular use it to continue the development of allergies or severe medical complications of drug use is prohibited.
3-Pregnancy
Age
From 30 years old to 42 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences- Hezar jarib Ave. - Isfahan
City
isfahan
Postal code
Approval date
2012-06-21, 1391/04/01
Ethics committee reference number
394067
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
ovarian reserve hormones ( FSH-LH-Progestrone-E2)
Timepoint
end of each cycle
Method of measurement
laboratory assessment
2
Description
Antral follicles numbers
Timepoint
end of each cycle
Method of measurement
sonography
3
Description
Antral follicles size
Timepoint
end of each cycle
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
1 mg daily of placebo gel (10 mg) on the external surface of the thigh in the control group
Category
Treatment - Drugs
2
Description
1 mg daily testosterone gel 1% (10 mg) on the external surface of the thigh in the intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
isfahan shahid beheshti hospital
Full name of responsible person
Street address
City
isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
research management
Street address
School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.
City
isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University 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
medical science school
Full name of responsible person
atena khayambashi
Position
Obstetrics and Gynecology resident
Other areas of specialty/work
Street address
isfahan medical scineces university
City
isfahan medical science school
Postal code
Phone
+98 939 683 1763
Fax
Email
atena_khayambashi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.
City
isfahan
Postal code
Phone
+98 913 113 4081
Fax
Email
Tehrani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical scienses
Full name of responsible person
atena khayambashi
Position
resident
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)