Evaluation of endometrial peeling on success rate of IVF in recurrent implantation failure in Yas Hospital
Design
A randomized, single-blind clinical trial, with two parallel groups, sample size 64; randomization using lottery method without replacement
Settings and conduct
In a randomized blinded clinical trial 64 patients with recurrent implantation failure in Yas hospital, will be allocated in resectoscopy for peeling endometrium (case group) or hysteroscopy for scratching endometrium (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age < 40; FSH <12; normal uterine cavity in vaginal ultrasound; normal hysterosalpingography.
Exclusion criteria: any lesion at hysteroscopy; absence of at least two good quality embryos.
Intervention groups
Intervention group: endoscopy and endometrial peeling. Control group: hysteroscopy and endometrial abrasion.
Main outcome variables
Chemical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N24
Registration date:2022-02-17, 1400/11/28
Registration timing:registered_while_recruiting
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
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
2022-01-28, 1400/11/08
Expected recruitment end date
2023-03-14, 1401/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial peeling of uterine cavity on the success rate of IVF in women with a history of implantation failure
Public title
The effect of endometrial peeling on the success rate of recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FSH<12
Normal uterus in transvaginal sonogram
Normal hysterosalpingography
History of implantation failure
Exclusion criteria:
Any lesion in the uterine cavity in hysteroscopy
Less than two good quality embryos
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: At first, on special unmarked papers, 32 A letters and 32 B letters are written. Then all are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly without replacement. Based on the letter written on it, the intended intervention is performed on the patient. In addition, interventions A (endometrial peeling) or B (control group) are determined by lottery.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are blinded regarding allocation in case or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Yas Hospital North nejatollahi avenue, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Approval date
2022-01-29, 1400/11/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1264
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
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
BhCG mu/dl
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Visualisation of fetal heart beat at vaginal ultrasound
Intervention groups
1
Description
Intervention group: Peeling of endometrium by resectoscopic loop catheter without electrical energy in32 patients
Category
Treatment - Surgery
2
Description
Control group: Scraching of endometrium by hysteroscoy
Category
Treatment - Surgery
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
159781597878
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
Mis.Ahmadi
Street address
Fifth floor-central building of Tehran University of Medical sciences, Ghods avenue-Keshavarz
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
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
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
159781597878
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
Yas hospital-North Nejatollahi avenue-Karim khan zand Bridge-Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
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
Yas hospital- North Nejatollahi avenue-Karim khan zand Bridge-Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD