The Investigating of effect indomethacin suppositories on pregnancy outcomes in IVF candidates with a history of more than two failed embryo transfers.
Determination of the effect of indomethacin suppository on pregnancy outcome in IVF candidates with a history of more than two unsuccessful embryo transfers.
Design
In a randomized clinical trial with the parallel control group, double-blind; Phase 2-3, on 120 patients; randomization is performed by using block randomization
Settings and conduct
This is a double-blind, parallel clinical trial that will be conducted on 120 IVF candidate patients at Fatemieh Hospital in Hamedan. The researcher who measures and records the outcomes and the patients who receive the intervention are unaware of the type of intervention, so the study is conducted as a double-blind trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 40 years, a history of at least two unsuccessful embryo transfers, having at least two A-grade embryos, unknown causes of IVF failure, and a body mass index (BMI) less than 30 kg/m².
Exclusion criteria:a history of any sensitivity to NSAIDs, uncontrolled chronic diseases, and prohibition of NSAID use.
Intervention groups
In the intervention group, participants received 100 milligrams of Indomethacin suppository manufactured by Darou Pakhsh-Iran one hour before embryo transfer and 12 hours after the first dose, but the control group does not receive this drug.
Main outcome variables
Determination of chemical and clinical pregnancy in two study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N29
Registration date:2023-12-02, 1402/09/11
Registration timing:prospective
Last update:2023-12-02, 1402/09/11
Update count:0
Registration date
2023-12-02, 1402/09/11
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-15, 1402/09/24
Expected recruitment end date
2024-01-22, 1402/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigating of effect indomethacin suppositories on pregnancy outcomes in IVF candidates with a history of more than two failed embryo transfers.
Public title
Indomethacin suppositories on pregnancy outcomes in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 40 years,
History of at least two unsuccessful embryo transfers,
Having at least two A-grade embryos, unknown causes of IVF failure
Unknown causes of IVF failure
Body mass index (BMI) less than 30 kg/m²
Exclusion criteria:
History of any sensitivity to NSAIDs,
Uncontrolled chronic diseases,
Prohibition of NSAID use
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will randomly assign the cases to intervention and control groups. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are removed. The four paper sheets will be then placed back into the container, and this action will be repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who examines patients for outcomes is not informed of the allocation of patients to the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-11-24, 1402/09/03
Ethics committee reference number
IR.UMSHA.REC.1402.558
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 day after embryo transfer
Method of measurement
The B- hCG level is greater than 20 IU/L after 14 days of embryo transfer,
2
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer” in English 1
Method of measurement
The sight of a pregnancy sac accompanied by the fetal heartbeat 4 weeks after embryo transfer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the transfer cycle are given Suppression (FET long) and then receive 100 mg Indomethacin suppositories made by Darou Pakhsh-Iran one hour before embryo transfer and 12 hours after the first dose. Then both groups continue their transfer medications uniformly according to the protocol, and 14-12 days after the transfer, a pregnancy test is performed. If it is positive, an ultrasound is performed for pregnancy sac and fetal heart at weeks 6 and 8.
Category
Treatment - Drugs
2
Description
Control group: This group receives the same intervention protocol without receiving indomethacin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Shamim Pilehvari
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 912 915 6058
Email
sh.heidari2016@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Pilehvari
Position
Hamadan
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 901 945 0846
Email
sh.heidari2016@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shokufe Heidari Farah
Position
Hamadan
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 901 945 0846
Email
sh.heidari2016@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shokufe Heidari Farah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
sh.heidari2016@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