Evaluation of pregnancy rate in RIF patients after injection of Gh via intrauterine route.
Design
Randomized double blind clinical trial, with 30 patients who are allocated in each parallel group, This is phase 3 trial that for randomization 30 A and 30 B letters will be enveloped in a pocket,and every patient will choose one letter. Physician who will evaluate the outcome and analyser will be blinded regarding groups.
Settings and conduct
At IVF clinic of Yas hospital this randomized double blinded clinical trial with case (Intra uterine infusion Gh at 6th day of esterogen replacement) and control (after transvaginal sonogram esterogen replacement continues) groups will be conducted by using random allocation method , the physician who will be evaluated the outcome and analyser are blinded regarding groups.
Participants/Inclusion and exclusion criteria
Thirty patients with history of recurrent implantation failure , and having good quality embryo, without uterine anomaly or adhesion, who had no response to routine treatment,will be included in the trail.
Intervention groups
Intervention group: After six days of estrogen therapy, Gh will be injected into uterine cavity by IUI catheter, for RIF.
Control group: After six days of estrogen therapy, transvaginal sonogram will be done and esterogen continued for RIF.
Main outcome variables
Chemical and clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N34
Registration date:2023-10-06, 1402/07/14
Registration timing:prospective
Last update:2023-10-06, 1402/07/14
Update count:0
Registration date
2023-10-06, 1402/07/14
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
2023-10-12, 1402/07/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of growth hormone (Gh) on pregnancy outcome of recurrent implantation failure (RIF) via intrauterine infusion.
Public title
Effect of Gh on pregnancy outcome in RIF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of recurrent implantation failure due to unknown etiology
Having good quality mbryo
Exclusion criteria:
User of corticosteroids
User of glucose control agents
CNS tumors
Uterine malformations
Asherman syndrome
Cavity distorting lesions
Severe endometriosis
Liver disease
Severe male infertility
Body mass index(BMI)>30
Uncontrolled hypothyroidism
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At First 30 letters A and 30 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patients. In addition, interventions A (case group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator physician differs from the care provider and analyzer only sees the codes in data sheet and are blinded regarding the groups but patients and care provider(who will done randomization) are not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
159781597815
Approval date
2023-08-26, 1402/06/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.285
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Beta HCG titer test (blood test)
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Heart beat activity by transvaginal sonogram
Intervention groups
1
Description
Intervention group: for thirthy patients, intracavitary growth hormone will be injected by IUI (Intrauterine Insemination) catheter one cm above internal OS cervix, 0.5 cc of Gh(Cinatrop Pen, cinagen company) at the 6th day of esterogen replacement therapy,after transvaginal sonogram.
Category
Treatment - Drugs
2
Description
Control group:At the sixth day of estrogen therapy at 30 patients,vaginal sonogram for evaluating endometrial thickness will be performed and estrogen will be continued.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
15978 1597815
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Deputy of Research of Tehran University medical sciences,central building, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
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
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
+98 21 8880 0115
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
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
+98 21 8880 0115
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
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
009888800115
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
Undecided - It is not yet known if there will be 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 of primary and secondary outcomes
When the data will become available and for how long
After publishing article
To whom data/document is available
To researchers of this filed
Under which criteria data/document could be used
Writing in the reference list
From where data/document is obtainable
By email
What processes are involved for a request to access data/document