Protocol summary

Study aim
Investigating intravenous(IV) intralipid administration in people with recurrent implantation failure(RIF) during IVF/ICSI cycles.
Design
Clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 70 patients. The rand function of Excel software was used for randomization.
Settings and conduct
70 infertile patients with a history of frequent unexplained implantation failure referred to the infertility department of Taleghani Hospital of Tehran who were candidates for frozen embryos were randomly divided into two interventions. control groups and the intervention group received intralipid on the first day of progesterone, positive pregnancy test, and 5 weeks after embryo transfer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: embryos in ≤35 years and or at least 4 Day-3 embryos≥ 35 years old with Idiopathic RIF and: normal hormonal profile of FSH, LH , TSH, PRL, and AMH; normal uterine cavity by hysteroscopy; body mass index  20–32 kg/m2; normal oocytes and embryos(grade A;B). Exclusion criteria: Women with recurrent miscarriages; with obvious reasons for IVF failure such as fibroids or polyps as assessed by hysteroscopy, age over 40 years, women undergoing donor egg IVF, low-quality embryos, severe endometriosis; contraindications for coagulation disorders, high cholesterol, liver disease, sickle cell disease; allergic to egg, lecithin or soy products.
Intervention groups
The intervention group receiving IV intralipid in patients with a history of RIF who are candidates for frozen embryo transfer(FET) and investigating pregnancy outcomes. The control group without receiving intralipid in patients with a history of RIF who are candidates for FET and investigation of pregnancy outcomes in them.
Main outcome variables
Implantation rate, Biochemical pregnancy rate, Clinical pregnancy rate, Ongoing pregnancy rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221016056198N2
Registration date: 2023-03-16, 1401/12/25
Registration timing: registered_while_recruiting

Last update: 2023-03-16, 1401/12/25
Update count: 0
Registration date
2023-03-16, 1401/12/25
Registrant information
Name
Nazanin Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2600
Email address
hajizadeh.nazanin94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous intralipid administration on reproductive outcomes for couples with recurrent implantation failure in non-donor in vitro fertilization /intracytoplasmic injection cycles
Public title
The effect of intralipid in recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with history of recurrent implantation failure who aged less than 40 years Patients with normal hormone profile Patients with BMI 20-32
Exclusion criteria:
Women with recurrent pregnancy loss Women with aged more than 40 years Women with endometriosis Women with coagulation disorder Women with allergy to soya and egg Women with Liver, Heart and Renal disease Women with high cholestrole
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with a history of repeated implantation failure in IVF cycles were divided into two groups receiving intralipid and a control group without receiving intralipid, who were assigned to one of the two treatment methods based on the randomization method with permutation blocks using Random Excel software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were unaware of the study group assignment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic commitee of Shahid Beheshti University Of Medical Science
Street address
Arabi avenue, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.850

Health conditions studied

1

Description of health condition studied
Infertile patient with recurrent implantation failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Implantation rate :The ratio of implanted embryos to transferred embryos
Timepoint
7 weeks after embryo transfer
Method of measurement
Vaginal Sonography

Secondary outcomes

1

Description
Biochemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group : Patients with a history of repeated implantation failure receiving Intralipid in embryo freeze transfer cycles
Category
Treatment - Drugs

2

Description
Control group : Patients with a history of repeated implantation failure receiving Intralipid in embryo freeze transfer cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Nazanin Hajizadeh
Street address
Araabi street, Velanjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Fax
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Velenjak St
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
20
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak Street, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arabi Ave, Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com

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
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