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Completed

NCT Number: NCT03862586

NAC Effect on Hox Genes Expressions in RIF

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl cysteine

Drug

Other names: NAC

Placebos

Drug

Other names: Placebo effervescent tablet

Primary outcomes

  1. Expression of HOXA in endometrium

    Time frame: approximately 20 days after the first day of menstruation (each day is 28 days)

    mRNA expression by quantitative PCR for homeo box A

Secondary outcomes

  1. Positive pregnancy test

    Time frame: 16 days after embryo transfer

    Measurement of quantitative serum β-hCG

  2. Endometrium thickness

    Time frame: approximately 20 day after the first day of menstruation (each day is 28 days)

    Endometrium thickness

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2019
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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