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NAC Effect on Hox Genes Expressions in RIF

Primary Purpose

Female Infertility

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
N-acetyl cysteine
Placebos
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility focused on measuring Implantation, Recurrent implantation failure, N-acetyl cysteine, HOXA cluster genes, Window of implantation

Eligibility Criteria

22 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 20 and 40 years old
  2. At least two IVF failure
  3. BMI in the normal range

Exclusion Criteria:

  1. Irregular menstrual cycle
  2. Taking hormonal drugs except thyroid medication
  3. Abnormal karyotype or chromosomal disorders
  4. Coagulation problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    N-acetyl cysteine

    Placebos

    Arm Description

    Twenty two infertile women with the onset of endometrial preparation for evaluating genes expression, received 1200 mg of oral N-acetyl cysteine for at-least six weeks before starting ovarian stimulation

    Eighteen infertile women with the onset of endometrial preparation for evaluating genes expression, received placebo effervescent tablet for at-least six weeks before starting ovarian stimulation

    Outcomes

    Primary Outcome Measures

    Expression of HOXA in endometrium
    mRNA expression by quantitative PCR for homeo box A

    Secondary Outcome Measures

    Positive pregnancy test
    Measurement of quantitative serum β-hCG
    Endometrium thickness
    Endometrium thickness

    Full Information

    First Posted
    December 23, 2018
    Last Updated
    March 2, 2019
    Sponsor
    Royan Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03862586
    Brief Title
    NAC Effect on Hox Genes Expressions in RIF
    Official Title
    Effect of N-Acetyl Cysteine on Expression of HOXA Cluster Genes in Endometrium of Women With Recurrent Implantation Failure (RIF) During Implantation Window: a Double-blinded Randomized Research
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royan Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Comparison of the group treated with NAC-supplementation and placebo- administered groups showed elevations in HOXA cluster genes (all members) expression level in endometrium of women with RIF.
    Detailed Description
    Despite significant developments in assistant reproductive technology (ART) that have overcome many underlying causes of infertility, pregnancy success rates remain relatively low, mainly due to implantation failure. Embryo quality and endometrial receptivity are two significant factors that believed to be the key points in implantation. Since recent studies that showed high expression of some HOXA genes affects on successful implantation rate, thus we examined the expression of HOXA genes in NAC supplementation during window of implantation (WOI) in women with (RIF). Also the effect of NAC on the improvement of implantation in RIF patients was investigated. Forty unfertile women with a diagnosis of RIF, referred to Royan Institute were included in the study. The study was of the type a single center, double blinded, placebo controlled, randomized trial. Expression of HOXA genes were assessed on the day of WOI (using Real Time PCR) biopsies from endometrium. Subjects randomly assigned to receive either NAC (A) or placebo (B) with both effervescent tablets having similar color, size and appearance. The patients were randomly categorized in two groups (A/B) to receive NAC 1200 mg/day or placebo, for at-least 6 weeks before starting ovarian stimulation. Pipelled-based biopsy from endometrium was done on specific day (19-21) of their cycle. Then patients were undergone ovarian stimulation (using NAC) ended to IVF treatment. RNA extraction and cDNA synthesis were performed from endometrium samples and then we evaluated expressions levels by Real-time PCR. Then we analyzed our data by independent Sample T-test and Mann-whitney U Test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Infertility
    Keywords
    Implantation, Recurrent implantation failure, N-acetyl cysteine, HOXA cluster genes, Window of implantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    N-acetyl cysteine
    Arm Type
    Experimental
    Arm Description
    Twenty two infertile women with the onset of endometrial preparation for evaluating genes expression, received 1200 mg of oral N-acetyl cysteine for at-least six weeks before starting ovarian stimulation
    Arm Title
    Placebos
    Arm Type
    Placebo Comparator
    Arm Description
    Eighteen infertile women with the onset of endometrial preparation for evaluating genes expression, received placebo effervescent tablet for at-least six weeks before starting ovarian stimulation
    Intervention Type
    Drug
    Intervention Name(s)
    N-acetyl cysteine
    Other Intervention Name(s)
    NAC
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    Placebo effervescent tablet
    Primary Outcome Measure Information:
    Title
    Expression of HOXA in endometrium
    Description
    mRNA expression by quantitative PCR for homeo box A
    Time Frame
    approximately 20 days after the first day of menstruation (each day is 28 days)
    Secondary Outcome Measure Information:
    Title
    Positive pregnancy test
    Description
    Measurement of quantitative serum β-hCG
    Time Frame
    16 days after embryo transfer
    Title
    Endometrium thickness
    Description
    Endometrium thickness
    Time Frame
    approximately 20 day after the first day of menstruation (each day is 28 days)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 20 and 40 years old At least two IVF failure BMI in the normal range Exclusion Criteria: Irregular menstrual cycle Taking hormonal drugs except thyroid medication Abnormal karyotype or chromosomal disorders Coagulation problems.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Parvaneh Afsharian, PhD
    Organizational Affiliation
    Royan Institute
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ashraf Moini, MD
    Organizational Affiliation
    Royan Institute
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Seyed Mehdi Kalantar, PhD
    Organizational Affiliation
    Shahid Sadoughi University of Medical Sciences
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Maryam Shahhoseini, PhD
    Organizational Affiliation
    Royan Institute
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Vida Mokhtari, MSc
    Organizational Affiliation
    Royan Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    NAC Effect on Hox Genes Expressions in RIF

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