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NAC Effect on Hox Genes Expressions in RIF

Sponsor
Royan Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03862586
Collaborator
(none)
40
Enrollment
2
Arms
28.9
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: N-acetyl cysteine
  • Drug: Placebos
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: N-acetyl cysteine

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

Drug: N-acetyl cysteine
Other Names:
  • NAC

    		•
    Placebo Comparator: Placebos

    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

    Drug: Placebos
    Other Names:
  • Placebo effervescent tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Expression of HOXA in endometrium [approximately 20 days after the first day of menstruation (each day is 28 days)]

      mRNA expression by quantitative PCR for homeo box A

    Secondary Outcome Measures

    1. Positive pregnancy test [16 days after embryo transfer]

      Measurement of quantitative serum β-hCG

    2. Endometrium thickness [approximately 20 day after the first day of menstruation (each day is 28 days)]

      Endometrium thickness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Royan Institute

    Investigators

    • Study Director: Parvaneh Afsharian, PhD, Royan Institute
    • Study Chair: Ashraf Moini, MD, Royan Institute
    • Study Chair: Seyed Mehdi Kalantar, PhD, Shahid Sadoughi University of Medical Sciences
    • Study Director: Maryam Shahhoseini, PhD, Royan Institute
    • Principal Investigator: Vida Mokhtari, MSc, Royan Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royan Institute
    ClinicalTrials.gov Identifier:
    NCT03862586
    Other Study ID Numbers:
    • Royan-Genetics
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Royan Institute
    Implantation
    Recurrent implantation failure
    N-acetyl cysteine
    HOXA cluster genes
    Window of implantation
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Acetylcysteine
    N-monoacetylcystine

    Study Results

    No Results Posted as of Mar 5, 2019