the effecacy of biofeedback and neuromuscular stimulation in Increasing the thickness of endometrium more than 7 millimeter with vaginal sonography in women 24 t0 45 years old that uterin thin and less of 7 millimeter endometrium despite received estrogen and progestron during embryo transfer
Crises fertility at fetal transfer with crises uterine Endometrial that is important factor in fertility
Design
TWO arm parallel group randomised trial with blinded postoperative care and outcom assessment
Settings and conduct
From infertility injuries andwant embryo transfer to Sarem hospital ,a midwife accepts randomly individual who control and control the conditions of the plan
Participants/Inclusion and exclusion criteria
Woman's with aged 24 to45 years and 2 time canseled. transfer reason endometrial uterine less 7 milimeter without chronic disease
Intervention groups
Infertility woman
Main outcome variables
Increased endometrial thickness, increased blood flow to the uterus and fertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190212042685N1
Registration date:2019-07-03, 1398/04/12
Registration timing:registered_while_recruiting
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
Registrant information
Name
Mehri Nejat
Name of organization / entity
Sarem Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 4604 0339
Email address
sepantareshadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-06, 1398/03/16
Expected recruitment end date
2020-06-05, 1399/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effecacy of biofeedback and neuromuscular stimulation in Increasing the thickness of endometrium more than 7 millimeter with vaginal sonography in women 24 t0 45 years old that uterin thin and less of 7 millimeter endometrium despite received estrogen and progestron during embryo transfer
Public title
biofeedback and neuromuscular stimulation in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
24_45
Canceled 2 time. Emberyo transfer to cause thin thickness uterine
There are 2 fetal
Simple Accident. Blind ,the midwife of adolescents from 24 to 45 year_old women with a condio al design including two consecutive embryo transfer sequences due to thinness of thoracic endometrium and two_part freeze with out chronic disease were randomly divided into control and international groups without any knowledge of the clients.Each group in the control group ,only the homonthrapy is performed according to the previous procedure and biofeedback and neuromuscular stimulation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients don't information about control and intervatuion groups both groups receive an endometrial treatment by a gynecologist and the midwife divides the admission into the control and intermediate group
Placebo
Not used
Assignment
Single
Other design features
Biofeedback and. neuromuscular stimulation is physiotherapy unit with vaginal prop cause increase plvic blood supply
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics committee on Bit medical Research
Street address
BlokA,13th.Floor.,Ministry of Health and Medical education, South of South falamak-Ghoss-Theran
City
tehran
Province
Tehran
Postal code
۱۴۷۱۴۷۲۳۴۱
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.IUMS.REC.1۳۹۷.۹۸۴
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Increasing the thickness of the uterin endometer over 7 millimeter
Timepoint
3,6,12 day
Method of measurement
Vaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: women aged 24 to 45 without chronic diseases with 2 times canceling of embryo transfer dup to thickness of uterine endometrium
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem hospital
Full name of responsible person
Mehri nejat
Street address
Sarem hospital,fazeh1-Ekbatan
City
tehran
Province
Tehran
Postal code
1476612325
Phone
+98 21 4463 3284
Email
sepantareshadi@gmail.com
2
Recruitment center
Name of recruitment center
Cent sexual disease Agapeh
Full name of responsible person
Mehri nejat
Street address
N.1,narges ale, Shiraz North sth. -molasadera-vanac
City
tehran
Province
Tehran
Postal code
۱۴۷۲۳۶۵۷۸۹
Phone
+98 21 8804 0283
Email
sepantareshadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sarem hospital
Full name of responsible person
Abotaleb sarem
Street address
Sarem hospital,fazed 1,Ekbatan
City
tehran
Province
Tehran
Postal code
۱۴۷۲۳۴۵۶۹۸
Phone
+98 21 4469 7012
Email
sepantareshadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Agapeh clinic
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Agapehclinic
Full name of responsible person
Mehri nejat
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
N.37,hidari moghadam st.,ponak squeeze.
City
tehran
Province
Tehran
Postal code
۱۴۷۶۶۱۲۳۲۵
Phone
+98 21 4604 0331
Email
sepantareshadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Agapehclinic
Full name of responsible person
Mehrinejat
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
N.37,hidari moghadam st., ponak square.
City
tehran
Province
Tehran
Postal code
۱۴۷۶۶۱۲۳۲۵
Phone
+98 46040339
Email
sepantareshadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Agapehclinic
Full name of responsible person
Mehrinejat
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
N.37, hidari moghadam sth.,ponak square.
City
tehran
Province
Tehran
Postal code
۱۴۷۶۶۱۲۳۲۵
Phone
+98 21 4604 0339
Email
sepantareshadi@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
All of data 's without name and phone numbers ,analysis and conclusion will provide pdf and
archive at Agapehclinic and sarem hospital
When the data will become available and for how long
Without limitation
To whom data/document is available
Gynecologistsand midwives or physician
Under which criteria data/document could be used
People 's want to try in the same projects or treatment infertility patients