PCOSPhase 4NACIPCOSNCT01896492
Clomiphene Plus N-acetyl Cysteine for Induction of Ovulation in Newly Diagnosed Pcos.
A Phase 4 study testing NAC in people with PCOS, run by Woman's Health University Hospital, Egypt.
Trial summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- NAC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 4
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS diagnosed by Rotterdam's criteria
Who cannot join
- previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility
About this study
Official title: Clomiphene Citrate Plus N-acetyl Cysteine Versus Clomiphene Citrate for Induction of Ovulation in Women With Newly Diagnosed Polycystic Ovary Syndrome: a Randomized Double-blind Controlled Trial
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .
Clomiphene citrate remains the standard drug for induction or augmentation of ovulation. However, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in PCOS .
Read the detailed description
NAC has been used effectively as an adjuvant to clomiphene citrate (CC) for ovulation induction in CC-resistant women with PCOS .
Because it is an insulin sensitizer, NAC was proposed as an adjuvant to clomiphene citrate for ovulation induction in patients with polycystic ovary syndrome who are resistant to clomiphene citrate. Encouraging results in those patients stimulated us to investigate whether adding NAC to the standard treatment with CC results in a higher ovulation rate, higher pregnancy rate, and less CC resistance in women with newly diagnosed polycystic ovary syndrome using a randomized, double-blind, controlled study.
- Conditions
- PCOS
- Being tested
- NAC
- Keywords
- PCOS,, NAC,, OVULATION INDUCTION,, CLOMOPHEN CITRATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NACDrug
Also called N-acetyl cystien
NAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth.
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl cystien and clomiphen citrate | Active comparator | N-acetyl cystien and clomiphen citrate,in induction of ovulation in newly diagnosed PCOS,1-2gm schats of NAC PLUS 100 mg of cc in the therd day of the cycle till day 8,with monitoring of follicular growth usin ultrasonography.HCG is giving to trigger of ovulation fo follicular size 18mm or more. Receives: Drug: NAC |
| Clomiphen citrate and placebo | Placebo comparator | CC plus placebo compared to cc and NAC in induction of ovulation in PCOS new cases. Receives: Drug: NAC |
| N-acetyl cystien | No intervention | In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Clomiphene citrate, 100 mg, was given from day 3 until day 7. In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7. Monitoring of the cycle will involve transvaginal determination of the mean follicular diameter and measurement of serum E2 levels. Monitoring intervals will be determined by patient response.
Measured: 2 years
Secondary outcomes (1)
include PR, number of follicles of ≥ 18 mm, the serum E2 concentration, serum P, and endometrial thickness
Clomiphene citrate, 100 mg, was given from day 3 until day 7. In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7. Monitoring of the cycle will involve transvaginal determination of the mean follicular diameter and measurement of serum E2 levels. Monitoring intervals will be determined by patient response. Human chorionic gonadotropin will be given when at least one follicle measured 18 mm and the E2 level had increased. Timed intercourse will be advised 24-36 hours after hCG injection. A serum P level will be checked on cycle days 21-22.
A serum hCG level will be determined 14 days after hCG injection if menses had not yet occurred. Pregnancy will be defined as an increase in the serum hCG level on serial determinations at least 2 days apart.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
- Investigators
- Alaa M Ismail, M D, Principal investigator, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896492
- Sponsor's protocol ID
- ccpnacinovi
- Acronym
- NACIPCOS
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2013
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate Plus N-acetyl Cysteine Versus Clomiphene Citrate for Induction of Ovulation in Women With Newly Diagnosed Polycystic Ovary Syndrome: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01896492
- Acronym / sponsor ID
- NACIPCOS / ccpnacinovi
- Conditions
- PCOS
- Keywords
- PCOS,, NAC,, OVULATION INDUCTION,, CLOMOPHEN CITRATE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .
Clomiphene citrate remains the standard drug for induction or augmentation of ovulation. However, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in PCOS .
Detailed description
NAC has been used effectively as an adjuvant to clomiphene citrate (CC) for ovulation induction in CC-resistant women with PCOS .
Because it is an insulin sensitizer, NAC was proposed as an adjuvant to clomiphene citrate for ovulation induction in patients with polycystic ovary syndrome who are resistant to clomiphene citrate. Encouraging results in those patients stimulated us to investigate whether adding NAC to the standard treatment with CC results in a higher ovulation rate, higher pregnancy rate, and less CC resistance in women with newly diagnosed polycystic ovary syndrome using a randomized, double-blind, controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cystien and clomiphen citrate | Active comparator | Drug: NACN-acetyl cystien and clomiphen citrate,in induction of ovulation in newly diagnosed PCOS,1-2gm schats of NAC PLUS 100 mg of cc in the therd day of the cycle till day 8,with monitoring of follicular growth usin ultrasonography.HCG is giving to trigger of ovulation fo follicular size 18mm or more. |
| Clomiphen citrate and placebo | Placebo comparator | Drug: NACCC plus placebo compared to cc and NAC in induction of ovulation in PCOS new cases. |
| N-acetyl cystien | No intervention | –In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS diagnosed by Rotterdam's criteria
Key exclusion criteria (1 listed)
- previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility
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 |
|---|---|---|
| NACAlso: N-acetyl cystienNAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth. | Drug | Clomiphen citrate and placebo, N-acetyl cystien and clomiphen citrate |
Primary outcome
Ovulation rate
Time frame: 2 years
Clomiphene citrate, 100 mg, was given from day 3 until day 7. In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7. Monitoring of the cycle will involve transvaginal determination of the mean follicular diameter and measurement of serum E2 levels. Monitoring intervals will be determined by patient response.
1 secondary outcome
include PR, number of follicles of ≥ 18 mm, the serum E2 concentration, serum P, and endometrial thickness
Time frame: 2 years
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 12 Aug 2020.
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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.
Alaa M Ismail, M D principal investigator
Woman's Health University Hospital, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NAC in people with PCOS, run by Woman's Health University Hospital, Egypt.
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 1 inclusion and 1 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 12 Aug 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Ovulation rate (time frame: 2 years). 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 12 Aug 2020.