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Effect of N-acetyl cysteine on expression of Oxidation-Reduction genes of (FKBP4 ,PRDX6,NRF1,NRF2,GPX3 and MTHFR) during implantation window in women with Recurrent Implantation Failure: A Randomized, Placebo-Controlled, patient and assessor blinded, Phase 2 Clinical Trial

Protocol summary

Study aim
Effect of N-acetyl cysteine on the expression of Oxidation-Reduction genes of (NRF1, NRF2, GPX3, PRDX6, FKBP4, and MTHFR) during implantation window in women with Recurrent Implantation Failure
Design
A Randomized, Placebo-Controlled, patient and assessor blinded, Phase 2 Clinical Trial
Settings and conduct
Forty infertile women with a diagnosis of RIF referred to Royan Institute, will be included in this study and randomly will be divided into intervention and control groups. At the first step, they will be received 1200 mg of effervescent tablets of N-acetyl cysteine (NAC) daily or placebo about 6 weeks. The endometrial biopsy will be taken from patients by catheter biopsy (Pipelle) on 19-21th day in the cycle prior to IVF transfer procedure. In next cycle, these women will undergo routine infertile treatment and ovulation stimulation for IVF procedure and they will continue to take NAC or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 and 40 years old; at least twice implantation failure; BMI in the normal range. Patients prescribed drugs such as folic acid, iron, multivitamins, and supplements generally equal status. Exclusion criteria: Irregular menstrual cycle, taking hormonal drugs except thyroid medication, patients with abnormal karyotype or chromosomal disorders; patients who have coagulation problems.
Intervention groups
Intervention group: receive 1200 mg of effervescent tablets of N-acetyl cysteine (NAC) daily about 6 weeks. Control group: receive 1200 mg of effervescent tablets of placebo daily about 6 weeks.
Main outcome variables
Evaluation of Gene expression related to implantation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150831023831N2
Registration date: 2018-04-14, 1397/01/25
Registration timing: retrospective

Last update: 2018-04-14, 1397/01/25
Update count: 0
Registration date
2018-04-14, 1397/01/25
Registrant information
Name
Parvaneh Afsharian
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2674
Email address
pafshar@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2015-07-30, 1394/05/08
Actual recruitment end date
2016-04-24, 1395/02/05
Trial completion date
empty
Scientific title
Effect of N-acetyl cysteine on expression of Oxidation-Reduction genes of (FKBP4 ,PRDX6,NRF1,NRF2,GPX3 and MTHFR) during implantation window in women with Recurrent Implantation Failure: A Randomized, Placebo-Controlled, patient and assessor blinded, Phase 2 Clinical Trial
Public title
Effect of N-acetyl cysteine on expression of Oxidation-Reduction genes during implantation window in women with Recurrent Implantation Failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 40 years At least twice implantation failure BMI in the normal range Patients prescribed drugs such as folic acid, iron, multivitamins, and supplements generally equal status
Exclusion criteria:
Irregular menstrual cycle Taking hormonal drugs except thyroid medication Patients with abnormal karyotype or chromosomal disorders Patients who have coagulation problems
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 44
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and assessor are blinded
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Commitee of Royan Institue
Street address
Hafez St, Bani Hashem St, Resalat Ave
City
Tehran
Province
Tehran
Postal code
16635148
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.ACECR.ROYAN.REC.IR.ACECR.ROYAN.REC.1396.56

Health conditions studied

1

Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Gene expression related to implantation
Timepoint
9 weeks after intervention
Method of measurement
Real-time PCR

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
2 weeks after Embryo Transfer
Method of measurement
Measurement of quantitative serum β-hCG

Intervention groups

1

Description
Intervention group: administer 1200 mg of effervescent tablets of N-acetyl cysteine (NAC) daily about 6 weeks
Category
Treatment - Drugs

2

Description
Control group: administer1200 mg of effervescent tablets of placebo daily about 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
پژوهشگاه رویان
Full name of responsible person
دکتر پروانه افشاریان
Street address
Eastern Hafez street, Bani Hashem square, Resalat Highway
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Parvaneh Afsharian
Street address
Eastern Hafez street, Bani Hashem square, Resalat Highway
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Dr.Parvaneh Afsharian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Eastern Hafez street, Bani Hashem square, Resalat Highway
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Parvaneh Afsharian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Eastern Hafez street, Bani Hashem square, Resalat Highway
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Parvaneh Afsharian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Eastern Hafez street, Bani Hashem square, Resalat Highway
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org

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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