A Phase 3 interventional study of N-acetyl cysteine and Placebos in Female Infertility, sponsored by Royan Institute. Completed. Open to female participants aged 22 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Royan Institute · Phase 3, Interventional, and Treatment
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.
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.
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This study's enrollment of 40 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Exclusion Criteria:
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
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
Also known as: NAC
Also known as: Placebo effervescent tablet
Expression of HOXA in endometrium
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)
Positive pregnancy test
Measurement of quantitative serum β-hCG
Time frame: 16 days after embryo transfer
Endometrium thickness
Endometrium thickness
Time frame: approximately 20 day after the first day of menstruation (each day is 28 days)
No study locations are listed for this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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