Study of interalipid infusion efficacy in patients with a 2-time embryo transfer in the infertility center of Mazandaran University of Medical Sciences
Design
This clinical trial had a control group with parallel randomized groups with 80 patients, of which 40 were in the intervention group and 40 were in the control group.
Settings and conduct
This study is performed in the infertility center of Imam Khomeini Hospital in Sari • 80 patients are randomly placed in the control and intervention group who inject 20% solution of interalipid into the intervention group before embryo transfer and then transfer, the initial result of a positive test Pregnancy is possible, also this study is one-sided blind and the patient is considered blind
Participants/Inclusion and exclusion criteria
All mothers with a history of infertility are sampled. Patients who have been sampled have a history of 2 with embryo transfer.
Mothers with dangerous chromosomal abnormalities, antiphospholipid syndrome or a positive thrombophilia test, mothers with endocrine disorders, hyperlipidemia, allergies to eggs and their products are excluded from the study. Mothers over the age of 40 were also considered our exclusion criteria.
Intervention groups
Intervention group (Intralipid receptor): Intralipid receptor 20% solution in 250 cc of sterile saline, which is administered within two hours. Once between days 4 to 9 of ovarian stimulation and again on day 7 with a positive pregnancy test.
Control group of 40 people: the group that does not receive the intervention
Main outcome variables
Positive pregnancy test; wife fetal heart in week 6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140305016858N5
Registration date:2021-06-19, 1400/03/29
Registration timing:registered_while_recruiting
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Sepideh Peyvandi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4443 0501
Email address
drspeyvandi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of interalipid infusion for patients with a history of 2 unsuccessful embryo transfers
Public title
Evaluation of the effectiveness of interalipid infusion for patients with a history of 2 unsuccessful embryo transfers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a history of 2 embryo transfers are sampled.
Patients who are over 18 to 40 years old and have the necessary criteria for the IVF process
All mothers with a history of infertility
Exclusion criteria:
Mothers with dangerous chromosomal abnormalities
Mothers with dangerous abnormalities of antiphospholipid syndrome or positive thrombophilia test
Mothers with endocrine disorders
Mothers with hyperlipidemia disorders
Mothers who were allergic to eggs and their products
Mothers over 40 years old
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For this study, 80 sealed envelopes were prepared which were divided into two groups A and B and the relevant expert selected one envelope for each patient and the patient was randomly placed in the control or intervention group.
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 Mazandaran University of Medical Sciences Sari
Street address
Amir Mazandarani Blvd., Imam Khomeini Hospital, Department of Obstetrics and Gynecology, second floor
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.011
Health conditions studied
1
Description of health condition studied
Recurrent implantation failler
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Positive pregnancy test
Timepoint
Two weeks after transfer
Method of measurement
In Imam Khomeini Infertility Center, pregnancy test is performed by ELISA method
Secondary outcomes
1
Description
Record fetal heart rate at 6 weeks of gestation
Timepoint
Six weeks of pregnancy
Method of measurement
sonography
Intervention groups
1
Description
Control group:Intervention group (Intralipid receptor): Intralipid receptor 20% solution in 250 cc of sterile saline, which is administered within two hours. Once between days 4 to 9 of ovarian stimulation and again on day 7 with a positive pregnancy test.
Category
Other
2
Description
Control group: Control group: does not receive interalipid
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic Of Emam Khomaini Hospital
Full name of responsible person
MRs soltani-Mrs rasouli
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital (RA) Infertility Clinic
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
drspeyvandi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mr gholami
Street address
Sari 18th km sea roud.payambar aazam department
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
drspeyvandi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sepideh Peyvandi
Position
Associate Professor, Department of Obstetrics and Gynecology, Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Mazandarani St., Imam Khomeini Hospital (RA) Infertility Clinic
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
drspeyvandi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sepideh Peyvandi
Position
Associate Professor of Obstetrics and Gynecology - Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Mazandarani St., Imam Khomeini Hospital Infertility Clinic
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
009833361700-4
Fax
+98 11 3336 3754
Email
drspeyvandi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Leila Mortazavi
Position
Assistant to obstetricians
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Mazandarani Blvd., Imam Khomeini Hospital, Department of Obstetrics and Gynecology
City
SARI
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
LEILA.MTZV66@GMAIL.COM
Web page address
https://www.mazums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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