NCT03862586

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

December 23, 2018

Last Update Submit

March 2, 2019

Conditions

Female Infertility

Keywords

ImplantationRecurrent implantation failureN-acetyl cysteineHOXA cluster genesWindow of implantation

Outcome Measures

Primary Outcomes (1)

  • Expression of HOXA in endometrium

    mRNA expression by quantitative PCR for homeo box A

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

Secondary Outcomes (2)

  • Positive pregnancy test

    16 days after embryo transfer

  • Endometrium thickness

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

Study Arms (2)

N-acetyl cysteine

EXPERIMENTAL

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

Placebos

PLACEBO COMPARATOR

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

Interventions

N-acetyl cysteineDRUG
Also known as: NAC
N-acetyl cysteine
PlacebosDRUG
Also known as: Placebo effervescent tablet
Placebos

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 40 years old
  • At least two IVF failure
  • BMI in the normal range

You may not qualify if:

  • Irregular menstrual cycle
  • Taking hormonal drugs except thyroid medication
  • Abnormal karyotype or chromosomal disorders
  • Coagulation problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Parvaneh Afsharian, PhD

    Royan Institute

    STUDY DIRECTOR

  • Ashraf Moini, MD

    Royan Institute

    STUDY CHAIR

  • Seyed Mehdi Kalantar, PhD

    Shahid Sadoughi University of Medical Sciences

    STUDY CHAIR

  • Maryam Shahhoseini, PhD

    Royan Institute

    STUDY DIRECTOR

  • Vida Mokhtari, MSc

    Royan Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2018

First Posted

March 5, 2019

Study Start

February 1, 2015

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

March 5, 2019

Record last verified: 2019-03