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
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
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.
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
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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