Comparison of the efficacy of endometrial scraping in follicular and luteal phases in pregnancy rate of FET women referred to Fatemieh Hospital Infertility Center, Hamadan, Iran, during the years 2019-2020.
Design
In this single-blind study, patients (290 women) were randomly assigned into two groups: intervention group 1 and 2.
Settings and conduct
In this single-blind study, patients referred to Fatemieh Infertility Center in Hamadan were randomly divided into two groups. Patients in group 1 were scratched at the beginning of the follicular phase with the onset of estradiol with a pipple catheter. Patients in group 2 are scratched in the mid-lethal phase of the preceding cycle. Each group is given an NSAIDS compound half an hour before the procedure. Then the two groups will be compared regarding pregnancy success rate, duration of drug administration, estradiol dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women candidates for the freeze-frozen transfer cycle are 43 years old and younger and have at least two embryos with grade A and normal cavities. Exclusion criteria: absence of a fetus with a uterus above 7 mm
Intervention groups
Intervention group 1 patient who was scratched at the beginning of follicular phase with estradiol initiation with pipple catheter. Intervention group 2 patient phase means of the previous lottery cycle are scratched.
Main outcome variables
Success of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191031045292N1
Registration date:2019-12-16, 1398/09/25
Registration timing:registered_while_recruiting
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Shamim Pilehvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 7459
Email address
sh.pilehvar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of endometrial scratch with luteal phase versus follicular phase in FET women candidates outcome
Public title
Pregnancy by endometrial scratch
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for frozen embryo transfer cycles with at least two Grade A
Women candidates for frozen embryo transfer cycles with Two embryos with normal cavities
From 21 years old to 35 years old
Exclusion criteria:
The embryo without uterus above 7 mm
Age
From 25 years old to 43 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
290
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into treatment groups A and B using block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were randomly assigned to one of two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of Medical Sciences
Street address
Hamedan University of Medical Sciences, Opposite the Mardom Park
City
Hamadan
Province
Hamadan
Postal code
6516735537
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.UMSHA.REC.1398.615
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Success of pregnancy
Timepoint
14 days after IVF
Method of measurement
BHCG
Secondary outcomes
1
Description
Pregnancy
Timepoint
Eight weeks after intervention
Method of measurement
BHCG test, Observation of pregnancy sac and positive sonography
Intervention groups
1
Description
Intervention group 1: in the follicular phase, patients are scratched in four directions simultaneously with ultrasound and confirmation of estrogen initiation using a papillary catheter.Half an hour before the procedure, patients are given a combination of NSAIDS.
Category
Treatment - Surgery
2
Description
Intervention group 2: patients in the luteal phase are also scratched high on day 21–19 before estrogen is started. Half an hour before the procedure, patients are given a combination of NSAIDS.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hamadan
Full name of responsible person
Shamim Pilevari
Street address
Pasdaran Avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
sh.pilehvar@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamedan University of Medical Sciences, Opposite the Mardom Park
City
Hamadan
Province
Hamadan
Postal code
6516735537
Phone
+98 81 3827 7012
Email
Webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research,Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilevari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
sh.pilehvar@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilevari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
sh.pilehvar@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilevari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
sh.pilehvar@umsha.ac.ir
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