Clomiphene Citrate Resistant Polycystic Ovary SyndromePhase 2/3NACNCT02775734
NAC in CC Resistant PCOS After LOD
A Phase 2/3 study testing N-acetyl-cysteine and Clomiphene citrate in people with Clomiphene Citrate Resistant Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Clomiphene Citrate Resistant Polycystic Ovary Syndrome
- What is being tested?
- N-acetyl-cysteine and Clomiphene citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Mar 2017
- Phase
- Phase 2/3
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) between 25 and 30 Kg/m 2.
- CC-resistant Polycystic ovary syndrome
Who cannot join
- • Patients with BMI under 25 or over 30 Kg/m 2.
- Hyper or hypothyroidism, or hyperprolactinemia.
- Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Intention to start a diet or a specific program of physical activity.
- Organic pelvic diseases.
- Tubal or male factor infertility.
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- Interval of earlier treatment with any of the fertility drugs of less than 6 months.
- Contraindication to either:
- Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation
- HCG injection: ovarian enlargement or hyper stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial
This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.
- Being tested
- N-acetyl-cysteine, Clomiphene citrate
- Keywords
- Polycystic Ovary Syndrome, N-acetyl-cysteine, Clomiphene citrate, Clomiphene citrate resistant, Laparoscopic ovarian drilling, therapy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl-cysteineDrug
N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
Clomiphene citrateDrug
Clomiphene citrate + Laparoscopic ovarian drilling
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl-cysteine | Active comparator | N-acetyl-cysteine + Clomiphene citrate + LOD Receives: Drug: N-acetyl-cysteine; Drug: Clomiphene citrate |
| NO N-acetyl-cysteine | Active comparator | Clomiphene citrate + LOD Receives: Drug: Clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical pregnancy rate
Measured: 6 months
Secondary outcomes (7)
Clinical pregnancy rate
Measured: 6 months
Live-birth rate
Measured: 15 months
Ovulation rate
Measured: 6 months
follicles more than or equal 18 mm
Measured: 6 months
Pre-ovulatory endometrial thickness
Measured: 6 months
mid-luteal sub-endometrial doppler blood flow indices
Measured: 6 months
Incidence of side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clomiphene Citrate Resistant Polycystic Ovary SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775734
- Sponsor's protocol ID
- AS1275
- Acronym
- NAC
- Status last verified
- Apr 2017
- First submitted
- 16 May 2016
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02775734
- Acronym / sponsor ID
- NAC / AS1275
- Keywords
- Polycystic Ovary Syndrome, N-acetyl-cysteine, Clomiphene citrate, Clomiphene citrate resistant, Laparoscopic ovarian drilling, therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 May 2016 (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.
This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl-cysteine | Active comparator | Drug: N-acetyl-cysteine, Drug: Clomiphene citrateN-acetyl-cysteine + Clomiphene citrate + LOD |
| NO N-acetyl-cysteine | Active comparator | Drug: Clomiphene citrateClomiphene citrate + LOD |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 25 and 30 Kg/m 2.
- CC-resistant Polycystic ovary syndrome
Key exclusion criteria (10 listed)
- • Patients with BMI under 25 or over 30 Kg/m 2.
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-cysteineN-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling | Drug | N-acetyl-cysteine |
| Clomiphene citrateClomiphene citrate + Laparoscopic ovarian drilling | Drug | N-acetyl-cysteine, NO N-acetyl-cysteine |
Primary outcome
Biochemical pregnancy rate
Time frame: 6 months
7 secondary outcomes
Clinical pregnancy rate
Time frame: 6 months
Live-birth rate
Time frame: 15 months
Ovulation rate
Time frame: 6 months
follicles more than or equal 18 mm
Time frame: 6 months
Pre-ovulatory endometrial thickness
Time frame: 6 months
mid-luteal sub-endometrial doppler blood flow indices
Time frame: 6 months
Incidence of side effects
Time frame: 6 months
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 2 May 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing N-acetyl-cysteine and Clomiphene citrate in people with Clomiphene Citrate Resistant Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in 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 2 inclusion and 10 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 2 May 2017. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Biochemical pregnancy rate (time frame: 6 months). 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 2 May 2017.