Female InfertilityPhase 3NCT05460858
NAC Effect on Infertile Women With Endometrioma
A Phase 3 study testing N-acetyl cysteine in people with Female Infertility and Endometrioma, run by Royan Institute at 1 site in Iran.
Trial summary
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Female Infertility, Endometrioma, Stress Oxidative
- 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
- 140 participants
- Where
- 1 siteIran
- Study dates
- 13 Apr 2021to 30 Nov 2023
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 42 years
- Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV)
- Serum AMH levels between 0.7 and 4.5 ng/ml
- Standard long GnRH and antagonist ovulation stimulation cycle
- Body mass index (BMI) <30 kg/m2
Who cannot join
- Non-inclusion criteria: Congenital uterine malformations
- Severe male infertility (TESE, PESA)
- Past medical history of asthma
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran, 16635-148
Parvaneh Afsharian, PhD, +9821- 23562000, p.afsharian@royan-rc.ac.ir
About this study
Official title: Effect of N-acetyl Cysteine on Oxidative Stress Biochemical Factors and IVF/ICSI Outcomes in Women With Endometrioma: A Randomized, Double-blinded, Phase III Clinical Trial
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.
Read the detailed description
This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction.
Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique.
- Conditions
- Female Infertility, Endometrioma, Stress Oxidative
- Being tested
- N-acetyl cysteine, placebo
- Keywords
- en
- Medical subject headings
- Infertility, Female, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
One hundred and forty participants randomize in the intervention and placebo groups, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction. They will be received 1200 (2×600) mg of effervescent tablets of NAC or placebo daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl cystein | Experimental | Seventy participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique. Receives: Drug: N-acetyl cysteine |
| effervescent placebo | Placebo comparator | Seventy participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or antagonist induction, will be received 1200 (2×600) mg of effervescent placebo tablets daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MII oocyte number and quality
Observation of oocytes that were mature at the time of oocyte collection
Measured: Immediately after oocyte puncture
Secondary outcomes (8)
Measurement of TAC oxidative stress marker in blood plasma
Plasma will be obtained for studying TAC and measure by ELISA
Measured: Before intervention and 6 weeks after intervention
Measurement of SOD oxidative stress marker in blood plasma
Plasma will be obtained for studying SOD and measure by ELISA
Measured: Baseline and 6 weeks after intervention
Measurement of TAC oxidative stress marker in folicular fluid
Folicular fluid will be obtained for studying TAC and measure by ELISA
Measured: Immediately After oocyte puncture
Measurement of SOD oxidative stress marker in folicular fluid
Folicular fluid will be obtained for studying SOD and measure by ELISA
Measured: Immediately After oocyte puncture
Cleaved embryo numbers
2-3 days embryo from fertilization
Measured: 2-3 days after oocyte puncture
Blastocyst numbers
The stage the embryo reaches after 5 days in culture from the egg retrieval
Measured: 5 days after oocyte puncture and sperm insemination
Clinical pregnancy rate
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
Measured: 4-6 weeks after embryo transfer
Fertilization rate
Percentage of transformation of micro injected oocytes into two pronuclei embryo
Measured: 2-5 days after sperm insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start13 Apr 2021
- Primary completion23 Sep 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Parvaneh Afsharian, PhD, Principal investigator, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460858
- Sponsor's protocol ID
- Royan-NAC-Genetics
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 15 Jul 2022
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetyl Cysteine on Oxidative Stress Biochemical Factors and IVF/ICSI Outcomes in Women With Endometrioma: A Randomized, Double-blinded, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT05460858
- Acronym / sponsor ID
- Royan-NAC-Genetics
- Conditions
- Female Infertility, Endometrioma, Stress Oxidative
- Keywords
- en
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 23 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 15 Jul 2022 (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.
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.
Detailed description
This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction.
Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cystein | Experimental | Drug: N-acetyl cysteineSeventy participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique. |
| effervescent placebo | Placebo comparator | Drug: placeboSeventy participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or antagonist induction, will be received 1200 (2×600) mg of effervescent placebo tablets daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 42 years
- Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV)
- Serum AMH levels between 0.7 and 4.5 ng/ml
- Standard long GnRH and antagonist ovulation stimulation cycle
- Body mass index (BMI) <30 kg/m2
Key exclusion criteria (3 listed)
- Non-inclusion criteria: Congenital uterine malformations
- Severe male infertility (TESE, PESA)
- Past medical history of asthma
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 cysteineOne hundred and forty participants randomize in the intervention and placebo groups, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction. They will be received 1200 (2×600) mg of effervescent tablets of NAC or placebo daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. | Drug | N-acetyl cystein |
| placeboplacebo | Drug | effervescent placebo |
Primary outcome
MII oocyte number and quality
Time frame: Immediately after oocyte puncture
Observation of oocytes that were mature at the time of oocyte collection
8 secondary outcomes
Measurement of TAC oxidative stress marker in blood plasma
Time frame: Before intervention and 6 weeks after intervention
Measurement of SOD oxidative stress marker in blood plasma
Time frame: Baseline and 6 weeks after intervention
Measurement of TAC oxidative stress marker in folicular fluid
Time frame: Immediately After oocyte puncture
Measurement of SOD oxidative stress marker in folicular fluid
Time frame: Immediately After oocyte puncture
Cleaved embryo numbers
Time frame: 2-3 days after oocyte puncture
Blastocyst numbers
Time frame: 5 days after oocyte puncture and sperm insemination
Clinical pregnancy rate
Time frame: 4-6 weeks after embryo transfer
Fertilization rate
Time frame: 2-5 days after sperm insemination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
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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 principal investigator
Royan Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetyl cysteine in people with Female Infertility and Endometrioma, run by Royan Institute at 1 site in Iran.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Parvaneh Afsharian, PhD (+9821- 23562000, p.afsharian@royan-rc.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MII oocyte number and quality (time frame: Immediately after oocyte puncture). 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 15 Jul 2022.