Female InfertilityPhase 3NCT03862586
NAC Effect on Hox Genes Expressions in RIF
A Phase 3 study testing N-acetyl cysteine in people with Female Infertility, run by Royan Institute.
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. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 1 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 40 years old
- At least two IVF failure
- BMI in the normal range
Who cannot join
- Irregular menstrual cycle
- Taking hormonal drugs except thyroid medication
- Abnormal karyotype or chromosomal disorders
- Coagulation problems.
About this study
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
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.
Read the 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.
- Conditions
- Female Infertility
- Being tested
- N-acetyl cysteine, Placebos
- Keywords
- Implantation, Recurrent implantation failure, N-acetyl cysteine, HOXA cluster genes, Window of implantation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
PlacebosDrug
Also called Placebo effervescent tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of HOXA in endometrium
mRNA expression by quantitative PCR for homeo box A
Measured: approximately 20 days after the first day of menstruation (each day is 28 days)
Secondary outcomes (2)
Positive pregnancy test
Measurement of quantitative serum β-hCG
Measured: 16 days after embryo transfer
Endometrium thickness
Endometrium thickness
Measured: approximately 20 day after the first day of menstruation (each day is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Feb 2015
- Primary completion1 May 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Parvaneh Afsharian, PhD, Study director, Royan InstituteAshraf Moini, MD, Study chair, Royan InstituteSeyed Mehdi Kalantar, PhD, Study chair, Shahid Sadoughi University of Medical SciencesMaryam Shahhoseini, PhD, Study director, Royan InstituteVida Mokhtari, MSc, Principal investigator, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862586
- Sponsor's protocol ID
- Royan-Genetics
- Status last verified
- Mar 2019
- First submitted
- 23 Dec 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03862586
- Acronym / sponsor ID
- Royan-Genetics
- Conditions
- Female Infertility
- Keywords
- Implantation, Recurrent implantation failure, N-acetyl cysteine, HOXA cluster genes, Window of implantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cysteine | Experimental | Drug: N-acetyl cysteineTwenty 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 |
| Placebos | Placebo comparator | Drug: PlacebosEighteen 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 |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 40 years old
- At least two IVF failure
- BMI in the normal range
Key exclusion criteria (4 listed)
- Irregular menstrual cycle
- Taking hormonal drugs except thyroid medication
- Abnormal karyotype or chromosomal disorders
- Coagulation problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineAlso: NAC | Drug | N-acetyl cysteine |
| PlacebosAlso: Placebo effervescent tablet | Drug | Placebos |
Primary outcome
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
2 secondary outcomes
Positive pregnancy test
Time frame: 16 days after embryo transfer
Endometrium thickness
Time frame: approximately 20 day after the first day of menstruation (each day is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parvaneh Afsharian, PhD study director
Royan Institute
Ashraf Moini, MD study chair
Royan Institute
Seyed Mehdi Kalantar, PhD study chair
Shahid Sadoughi University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetyl cysteine in people with Female Infertility, run by Royan Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of HOXA in endometrium (time frame: approximately 20 days after the first day of menstruation (each day is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.