This is a randomized clinical trial for poor responder patients at IVF cycle. Patients with< 3 oocyte retrieved in past IVF cycle or AMH<1.2 or Antral follicle count<5 are defined as poor res-ponder. 120 women according to the table of randomization number divided in both group; at case group patients received tab Methyltestosterone 25 mg/d for 2 months, control group receive placebo tablet at the same time . All the patients signed informed consent before participating in study. Then at the 2th day of menstruation both group evaluate by transvaginalsonogram, and 300U FSH start for 5 days, then GnRH antagonist start and the gonadotropin continue until mature follicle 18-20 mm appear at TVS,then Ovitrell 250 mg for triggering inject. After 36 hour oocyte spick up schedule. The number of oocytes ,embryos, transferred embryo, and chemical and clinical pregnancy will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 35-42 y/o; history of<3 oocyte retrieved in past IVF cycle; AFC<5; AMH<1.2.
Exclusion criteria: history of ovarian surgery; systemic disease; abnormal profiles of the blood sugar, cholesterol or triglyceride; thyroid disorders; renal dysfunction; liver dysfunction.
Intervention groups
In case group patients use tablet methyl testosterone daily for two months before IVF cycle
Main outcome variables
Number of oocyte retrieved at OPU day; number of embryo at 3th day; B-hCG at 3th day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N16
Registration date:2018-06-17, 1397/03/27
Registration timing:registered_while_recruiting
Last update:2018-06-17, 1397/03/27
Update count:0
Registration date
2018-06-17, 1397/03/27
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the IVF outcome in Methyl Testosterone consumers with placebo group in women with poor ovarian response referring to Yas infertility center
Public title
Comparison the IVF outcome in Methyl Testosterone consumers with placebo group in women with poor ovarian response referring to Yas infertility center
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The number of oocytes punctured from them in previous cycles was less than or equal to 3
Antral follicle count less than 5
AMH less than 1.2
Exclusion criteria:
The history of ovarian surgery
Systemic disease
abnormal profiles of the blood sugar, cholesterol or triglyceride
Thyroid disorders
Renal dysfunction
Liver Dysfunction
Age
From 35 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the table of random numbers patients divide to two groups: in case group patients receive tablet methyl testosterone daily 2 months before starting IVF cycle, in control group patients receive placebo for two months, then both group start IVF cycle , oocytes are retrieved and counted, then at third day the embryos will be transferred to the uterus, the B-hCG results will be measured at 14th day after embryo transfer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Tehran University of Medical Sciences
Street address
Yas hospital, North Ostadnejatollahi, Karimkhan Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
1597856511
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.035
Health conditions studied
1
Description of health condition studied
Poor responder in IVF
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number of oocyte retrieved
Timepoint
In the day of oocyte puncture
Method of measurement
Number of oocyte retrieved
Secondary outcomes
1
Description
Number of embryo
Timepoint
Day 3 after injection
Method of measurement
Number of embryo
Intervention groups
1
Description
Intervention group: sixty patients include in the case group and use tablet methyletestesteron 25 mg, 1 daily, for 2 months before IVF cycle
Category
Treatment - Drugs
2
Description
Control group: Sixty patients in control group use placebo for 2 months before starting IVF cycle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas women Hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
North Ostad Nejatollahi- Villa street, Karimkhan Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0611
Email
fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss Atefeh Ahmadi
Street address
ِDeputy research of TUMS; Fifth floor of Central building of Tehran University of Medical Sciences, Ghodse Avenue, Keshavarz Boulvard
City
Tehran
Province
Tehran
Postal code
15897
Phone
+98 21 8116
Email
fatedavtanha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Ostad Nejatollahi- Villa street, Karimkhan Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0611
Email
fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi- Villa street, Karimkhan zand Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0611
Email
fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi- Villa street, Karimkhan bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0611
Email
fatedavtanha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data file anonymous
When the data will become available and for how long
After 3 years
To whom data/document is available
For University researchers
Under which criteria data/document could be used
For research projects
From where data/document is obtainable
Fatemeh Davari Tanha
What processes are involved for a request to access data/document
After acceptance of research deputy of Tehran University of Medical sciences , data will be present at 3-6 months