NAC Effect on Hox Genes Expressions in RIF

Female Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862586
• Other study ID #: Royan-Genetics
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: March 2019
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Drug:
• N-acetyl cysteine

• Placebos

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Positive pregnancy test	Measurement of quantitative serum ß-hCG	16 days after embryo transfer
Secondary	Endometrium thickness	Endometrium thickness	approximately 20 day after the first day of menstruation (each day is 28 days)