The effect of endometrial compression on pregnancy rate in embryo transfer cycles in infertile women IVF candidate of Imam Khomeini Hospital in Tehran in 2020-2021.
The aim of this study is to evaluate the effect of progesterone on endometrial thinning and the outcome of chemical l pregnancy; in embryo transfer cycles .
Design
A clinical trial with the control group, with parallel groups, phase 3 on 41 patients .
Settings and conduct
This study investigates the effect of progesterone endometrial thinning and the outcome of chemical pregnancy in embryo transfer cycles on 41 IVF and embryo transfer patients in two intervention and control groups referred to a university hospital. Before and after vaginal progesterone administration. The degree of change in endometrial thickness is measured by vaginal ultrasound.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Endometrial thickness is greater than or equal to 7 at the vaginal ultrasound, age less than 50 years, no underlying disease, first or second embryo transfer.
Exclusion criteria:
Uterine factor (adhesion; fibroids; polyps), smoking
Intervention groups
Intervention group: Candidate patients for IVF cycle who have vaginal progesterone suppository; They received 800 mg daily for 5 days.
Control group: Patients who are in the fetal transfer cycle on the last day before the start of progesterone and have not yet received progesterone.
Main outcome variables
Rate of change in endometrial thickness; Chemical pregnancy rate .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180624040214N3
Registration date:2021-06-29, 1400/04/08
Registration timing:prospective
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Mina Jafarabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2022-01-15, 1400/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial compression on pregnancy rate in embryo transfer cycles in infertile women IVF candidate of Imam Khomeini Hospital in Tehran in 2020-2021.
Public title
The effect of endometrial compaction on the occurrence of pregnancy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endometrial thickness greater than or equal to seven at the time of vaginal ultrasound
Age less than 50 years
Absence of underlying diseases
The first or second embryo transfer
IVF candidate
Exclusion criteria:
Uterine factor (adhesion; fibroid; polyps)
Being a smoker
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital
Street address
Research Development Building, Imam Khomeini Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.273
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Endometrial thickness change
Timepoint
Immediately before and one week after taking progesterone.
Method of measurement
Vaginal Sonography
Secondary outcomes
1
Description
Occurrence of chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: Candidate patients for IVF who underwent vaginal progesterone suppository for 5 days They receive 800 mg daily.
Category
Treatment - Drugs
2
Description
Control group: Candidate patients for IVF cycle who did not receive progesterone suppository.
6th floor, Ghods St, Keshavarz Blvd.Central Organization of the University, Deputy of Research and Technology of Tehran University of Medical Sciences .
City
Tehran
Province
Tehran
Postal code
۵۳۷۶۱-۱۴۱۷۶
Phone
+98 21 8163 3619
Email
m.sahraian@sina.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
Mina Jafarabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
minajaf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
minajaf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ّFedyeh Haghollahi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Vali Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
fedyeh_hagh@yahoo.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
patients privacy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available