Protocol summary

Summary
In spite of many researches in this field, more than 50% of transferred embryos don't implant in IVF/ICSI cycles. there are many causes of implantation failure : the most important of them are genetic, anatomic, immunologic,...and there are multiple treatments for them. recurrent implantation failure(RIF) is supposed when there are at least 2 unsuccessful embryo transferred cycles(fresh or freeze) with good quality embryos if female age is less than 40 years. immunological factors don't have fixed definition and treatments. there are some treatment such as prednisolone, IVIG, Intralipid,...and there are not any proved agreement about them. so we designed a double blind randomized clinical trial on 220 infertile women with RIF with immunological factors such as ANA+, ds DNA+, Antithyroid antibodies(Anti TG, Anti TPO)+, CD markers(CD16, CD56 or CD5, CD19)+ and we divided them randomly in two groups. they receive prednisolone 10 mg daily or placebo of prednisolone about 1.5 months before embryo transfer and continue drugs until 12 weeks of pregnancy in women who get pregnant and evaluate pregnancy rate, implantation rate and ongoing pregnancy rate until 12 weeks. treatment with prednisolone seem to improve ICSI outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016091618662N2
Registration date: 2016-09-19, 1395/06/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-19, 1395/06/29
Registrant information
Name
Farnaz Fatemi
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
f.fatemi@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility Clinic
Expected recruitment start date
2016-09-24, 1395/07/03
Expected recruitment end date
2018-03-24, 1397/01/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of prednisolone on ICSI outcomes in women with immunological recurrent implantation failure
Public title
Efficacy of Prednisolone on ICSI outcomes in a group of women with recurrent implantation failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: 1- At least 2 unsuccessful IVF/ICSI cycles 2- Grade A or AB of transferred embryos in previous cycles and at least 6 embryos transferred 3- Age<40years 4- FSH<15 5- Sperm>10 milion counts, >3% normal morphology Exclusion Criteria: 1- Utilization of donation systems 2- Uncontrolled diseases such as Diabetes, HTN, Lupus, Renal failures,... 3- Abnormal Katyotype 4- Anatomical abnormalities( congenital, submucosal myoma, Asherman syn,...) 5- Endometriosis grade 3, 4 6- Women who had Endometrial scratch in the same cycle
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Avicenna Research Institute Ethics Commitee
Street address
Avicenna Research Institute, Shahid Beheshti university, Velenjak Avenue, Chamran High way
City
Tehran
Postal code
1941913114
Approval date
2016-08-30, 1395/06/09
Ethics committee reference number
IR.ACECR.Avicenna.REC.1395.9

Health conditions studied

1

Description of health condition studied
unovulation female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility associated with anovulation

2

Description of health condition studied
tubal female inferility
ICD-10 code
N97.1
ICD-10 code description
Female infertility of tubal origin

3

Description of health condition studied
male factor female infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors

4

Description of health condition studied
unspecified female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified

5

Description of health condition studied
complication of artificial fertilization
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified

Primary outcomes

1

Description
ICSI Outcome(chemical pregnancy)
Timepoint
two weeks afert embryo transfer
Method of measurement
serum Beta HCG

2

Description
Clinical pregnancy
Timepoint
three weeks after embryo transfer
Method of measurement
transvaginal ultrasound

Secondary outcomes

1

Description
oocyte quality
Timepoint
on the oocyte collection day
Method of measurement
morphologic assesment with microscope

2

Description
embryo quality
Timepoint
2 or 3 days after oocyte collection
Method of measurement
morphologic assesment with microscope

3

Description
fertilization rate
Timepoint
2 or 3 days after oocyte collection
Method of measurement
(embros number/injected oocytes numbers) * 100

4

Description
prednisolone complications
Timepoint
any time of trial
Method of measurement
history and lab tests

Intervention groups

1

Description
placebo of prednisolone about 1.5 months
Category
Placebo

2

Description
prednisolone 10 mg daily about 1.5 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Infertility Clinic
Full name of responsible person
Dr Farnaz Fatemi
Street address
No. 97, Yakhchal st., Shariati avenu,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Dr Mohammad Mehdi Akhondi
Street address
No. 97, Yakhchal st., Shariati avenu,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Infertility Clinic
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Dr Farnaz Fatemi
Position
MD, OB&GYN, Infertility fellowship
Other areas of specialty/work
Street address
No. 97, Yakhchal st., Shariati avenu,Tehran, Iran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
Email
Dr.farnazfatemi@Gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Dr Farnaz Fatemi
Position
MD, OB & GYN, Infertility fellowship
Other areas of specialty/work
Street address
No. 97, Yakhchal st., Shariati avenu,Tehran, Iran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
Email
Dr.farnazfatemi@Gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Dr Farnaz Fatemi
Position
MD, OB & GYN, Infertility Clinic
Other areas of specialty/work
Street address
No. 97, Yakhchal st., Shariati avenu,Tehran, Iran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
Email
Dr.farnazfatemi@Gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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