Effectiveness of mefenamic acid administration on the outcome of frozen-thawed embryo transfer in infertile women
Design
A clinical trial with a control group, with parallel groups
Settings and conduct
200 patients are involved in this study. There are 100 patients in the intervention group and the control group. In contrast to the control group, patients in the intervention group were prescribed 250 mg mefenamic acid capsules made by Elhawi Pharmaceutical Company one to two hours before embryo transfer. It is done in Shariati Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age less than 42 years and all patients who entered the cycle and frozen embryos due to infertility caused by male factors, tubal factors, endometriosis, decreased ovarian reserves, PCO and unexplained.
Exclusion criteria included lack of consent to participate in the study and structural abnormalities of the uterus confirmed by imaging or hysteroscopy. Patients who are not allowed to get pregnant for any reason.
Intervention groups
Intervention group: Patients in the intervention group are prescribed 250 mg mefenamic acid capsules manufactured by Elhawi Pharmaceutical Company one to two hours before embryo transfer.
Control group: patients in the control group do not receive mefenamic acid before embryo transfer. Then, the embryo is transferred into the uterus using a sterile embryo transfer catheter.
Main outcome variables
Increased serum B-HCG level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061800N2
Registration date:2024-07-04, 1403/04/14
Registration timing:retrospective
Last update:2024-07-04, 1403/04/14
Update count:0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
shahedeh khansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4643 2157
Email address
b_sh2110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effectiveness of mefenamic acid administration on the outcome of frozen-thawed embryo transfer in infertile women
Public title
Investigation of the effectiveness of mefenamic acid administration on the outcome of frozen-thawed embryo transfer in infertile women referred to Shariati Hospital, Tehran University of Medical Sciences in 2021
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 42 years
All patients who entered the cycle and have frozen embryos due to infertility caused by male factors, tubal factors, endometriosis, decreased ovarian reserve, PCO and unexplained.
Exclusion criteria:
Lack of consent to participate in the study
Structural abnormalities of the uterus confirmed by imaging or hysteroscopy.
Patients who are not allowed to get pregnant for any reason.
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
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 Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2022-06-18, 1401/03/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.220
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Increased serum B-HCG level
Timepoint
Two weeks after the intervention
Method of measurement
Biochemical tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group are prescribed 250 mg mefenamic acid capsules manufactured by Elhawi Pharmaceutical Company one to two hours before embryo transfer.
Category
Treatment - Drugs
2
Description
Control group: Control group patients do not receive mefenamic acid before embryo transfer. Then, the embryo is transferred into the uterus using a sterile embryo transfer catheter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
Ayda Najafian
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran
Province
Tehran
Postal code
1466938664
Phone
+98 21 8822 0050
Email
aidanajafian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhoondzadeh
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8822 0050
Email
aidanajafian@yahoo.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
Ayda Najafian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
aidanajafian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ayda Najafian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
aidanajafian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ayda Najafian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
aidanajafian@yahoo.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 data is potentially shareable after unidentified individuals
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
No other condition is considered
From where data/document is obtainable
aidanajafian@yahoo.com
What processes are involved for a request to access data/document