PCONCT04170439
Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO
A study testing Clomiphene plus metformin plus N acetyle cysteine in arm number 1, Clomiphene citrate plus metformin with chromium and clomiphene citrate plus metformin in people with PCO, run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
PCO is one of the factors associated with delayed conception Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCO
- What is being tested?
- Clomiphene plus metformin plus N acetyle cysteine in arm number 1, Clomiphene citrate plus metformin with chromium and clomiphene citrate plus metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Nov 2019to 15 May 2020
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCO
Who cannot join
- women who donot have PCO
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO
PCO is one of the factors associated with delayed conception
Read the detailed description
In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine
- Conditions
- PCO
- Being tested
- Clomiphene plus metformin plus N acetyle cysteine in arm number 1, Clomiphene citrate plus metformin with chromium, clomiphene citrate plus metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene plus metformin plus N acetyle cysteine in arm number 1Drug
oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium
Clomiphene citrate plus metformin with chromiumDrug
oral adminstration of clomiphene citrate plus metformin and chromium
clomiphene citrate plus metforminDrug
oral adminstration of clomiphene citrate plus metformin
| Study group | Role | What they receive |
|---|---|---|
| clomiphene plus metformin plus N acetyle cysteine | Other | Women who will receive clomiphene citrate plus metformin plus n acetyle cysteine Receives: Drug: Clomiphene plus metformin plus N acetyle cysteine in arm number 1 |
| clomiphene plus metformin plus chromium | Other | Women who will receive clomiphene plus metformin plus chromium Receives: Drug: Clomiphene citrate plus metformin with chromium |
| clomiphen citrate plus metformin | Other | Women who will receive clomiphene plus metformin Receives: Drug: clomiphene citrate plus metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles
Assessment of women in both groups for size and number of follicles
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start20 Nov 2019
- Primary completion2 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Study director, Algezeera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170439
- Sponsor's protocol ID
- chromium in infertility
- Status last verified
- Apr 2021
- First submitted
- 16 Nov 2019
- Last updated
- 28 Apr 2021
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO
- ClinicalTrials.gov ID
- NCT04170439
- Acronym / sponsor ID
- chromium in infertility
- Conditions
- PCO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 20 Nov 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.
PCO is one of the factors associated with delayed conception
Detailed description
In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
| Arm | Type | Receives |
|---|---|---|
| clomiphene plus metformin plus N acetyle cysteine | Other | Drug: Clomiphene plus metformin plus N acetyle cysteine in arm number 1Women who will receive clomiphene citrate plus metformin plus n acetyle cysteine |
| clomiphene plus metformin plus chromium | Other | Drug: Clomiphene citrate plus metformin with chromiumWomen who will receive clomiphene plus metformin plus chromium |
| clomiphen citrate plus metformin | Other | Drug: clomiphene citrate plus metforminWomen who will receive clomiphene plus metformin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with PCO
Key exclusion criteria (1 listed)
- women who donot have PCO
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 |
|---|---|---|
| Clomiphene plus metformin plus N acetyle cysteine in arm number 1oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium | Drug | clomiphene plus metformin plus N acetyle cysteine |
| Clomiphene citrate plus metformin with chromiumoral adminstration of clomiphene citrate plus metformin and chromium | Drug | clomiphene plus metformin plus chromium |
| clomiphene citrate plus metforminoral adminstration of clomiphene citrate plus metformin | Drug | clomiphen citrate plus metformin |
Primary outcome
The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles
Time frame: within 2 weeks
Assessment of women in both groups for size and number of follicles
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 28 Apr 2021.
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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.
Mahmoud Alalfy, PhD study director
Algezeera
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomiphene plus metformin plus N acetyle cysteine in arm number 1, Clomiphene citrate plus metformin with chromium and clomiphene citrate plus metformin in people with PCO, run by Aljazeera Hospital at 2 sites 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 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles (time frame: within 2 weeks). 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 28 Apr 2021.