Comparison of the effectiveness of intralipid in fertility rate in recurrent implantation failure (RIF) in frozen embryo transfer against the control group
1. Investigating the rate of chemical pregnancy in patients with recurrent implantation failure receiving Intralipid compared to the control group
2. rate of clinical pregnancy
3. rate of ongoing pregnancy
4. Rate of pregnancy over 24 weeks
Design
A controlled, parallel-group, randomized, phase 3 clinical trial on 160 patients. To randomize the rand function of Excel software
Settings and conduct
This study is conducted on the patients of the infertility department of Shariati Hospital who have had at least two failed embryo transfers and have referred to begin the frozen embryo transfer cycle. The selection of patients for the control and intervention groups is done by randomization using Excel software, and first the basic information of each patient is extracted, then the control group patients undergo endometrial preparation with the conventional method of the department and the intervention group in addition to the conventional method at the beginning of the freeze cycle, on the day transfer and if the pregnancy test is positive, three weeks after the transfer, will receive 100cc of Intralipid 20% SOMF. Then the rate of chemical, clinical and pregnancy over 16 and 24 weeks in two groups is compared
Participants/Inclusion and exclusion criteria
Patients candidates for frozen embryo transfer, who have had at least two unexplained failed frozen or fresh embryo transfers.
Exclusion criteria:
1. Age more than 42 years
2. BMI more than 35
3. Severe male infertility
4. AMH less than 1.5
5. Low quality embryo
6. Thrombophilia or Anti phospholipid syndrome
7. Abnormal uterine anatomy
8. Recurrent abortions
Intervention groups
recipient of 100 cc of intralipid 20%(SOMF) in beginning of freeze cycle ,day of embryo transfer and after 3 weeks of transfer if pregnancy test is positive
Main outcome variables
chemical ,clinical ,ongoing and more than 24 weeks pregnancy
General information
Reason for update
Acronym
RIF
IRCT registration information
IRCT registration number:IRCT20220725055555N1
Registration date:2022-09-10, 1401/06/19
Registration timing:registered_while_recruiting
Last update:2022-09-10, 1401/06/19
Update count:0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Seyyedeh Neda Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 8156
Email address
s.nedakazemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intralipid in fertility rate in recurrent implantation failure (RIF) in frozen embryo transfer against the control group
Public title
Effectiveness of intralipid in fertility rate in recurrent implantation failure (RIF) in frozen embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile patients with two or more implantation failures
Exclusion criteria:
Age more than42 years
BMI more than 35
Familial hyperlipidemia
Severe male factor infertility
AMH less than 1.5
Low quality embryo
Anatomical abnormality of uterus (Mullerian anomaly, sub mucosal fibroid , polyp ,hydrosalpinx ,.. )
Abnormal laboratory in liver function test, thyroid function test, prolactin, Lipid profile
Recurrent abortion history
Thrombophilia and anti phospholipid syndrome
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
randomization by rand function of Allocation of patients in two groups has been done by block random allocation method. Allocation sequence using the free web system www.sealedenvelope.com to generate the sequence, the number of subjects in each block is 4 and the letters A are for intervention group and letters B are for control. Finally, 72 samples (18 blocks) in two groups A and B have been produced.Excel Software
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
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
Jalale Al Ahmad
City
Tehran
Province
Tehran
Postal code
14111713135
Approval date
2022-07-29, 1401/05/07
Ethics committee reference number
IR.TUMS.MEDICIN.REC.1401.224
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pregnancy
Timepoint
check of pregnancy test after two weeks from embryo transfer
Method of measurement
beta -HCG t titer
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
ultrasound and check of fetal heart rate
2
Description
ongoing pregnancy
Timepoint
14 weeks after embryo transfer
Method of measurement
ultrasound
Intervention groups
1
Description
Intervention group: receive intralipid in addition of ward routine protocol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Seyyedeh Neda Kazemi
Street address
Jalale Ale Ahmad
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
s.nedakazemi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr . Akbar Fotohi
Street address
Keshavarz Blv . Qods Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@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
Seyyedeh Neda Kazemi
Position
post graduated fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalale Ale Ahmad
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
s.nedakazemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyedeh Neda Kazemi
Position
post graduated fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalale Ale Ahmad
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
s.nedakazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyedeh Neda Kazemi
Position
post graduated felloship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalale Ale Ahmad
City
Tehran
Province
Tehran
Postal code
14111713135
Phone
+98 21 8490 1000
Email
s.nedakazemi@gmail.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
Not applicable
Title and more details about the data/document
result data
When the data will become available and for how long
A Year after study
To whom data/document is available
Researchers in the academic place
Under which criteria data/document could be used
crude data
From where data/document is obtainable
Seyyede Neda Kazemi
s.nedakazemi@gmail .com
What processes are involved for a request to access data/document