InfertilityPhase 3NCT03241472
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
A Phase 3 study testing Letrozole and Clomiphene Citrate plus N acetyl cystine in people with Infertility, run by Assiut University.
Trial summary
Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Letrozole and Clomiphene Citrate plus N acetyl cystine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jun 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All primary and secondary. Infertility due to anovulation
Who cannot join
- Male factor infertility, tubal factor.
- Endocrineopathy
- Hypothyrodism
- Morbid obesity
- Under weight
- Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.
About this study
Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile
- Conditions
- Infertility
- Being tested
- Letrozole, Clomiphene Citrate plus N acetyl cystine
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
oral tablets 5 mg
Clomiphene Citrate plus N acetyl cystineDrug
Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
| Study group | Role | What they receive |
|---|---|---|
| Lertozole | Experimental | oral tablets 5 mg start from third day cycle for 5 days Receives: Drug: Letrozole |
| clomiphene plus N- acetyl cystiene | Active comparator | clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days Receives: Drug: Clomiphene Citrate plus N acetyl cystine |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of ovulation
ultrasound evaluation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startFeb 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241472
- Sponsor's protocol ID
- NACLET
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
- ClinicalTrials.gov ID
- NCT03241472
- Acronym / sponsor ID
- NACLET
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Aug 2017 (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.
Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lertozole | Experimental | Drug: Letrozoleoral tablets 5 mg start from third day cycle for 5 days |
| clomiphene plus N- acetyl cystiene | Active comparator | Drug: Clomiphene Citrate plus N acetyl cystineclomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All primary and secondary. Infertility due to anovulation
Key exclusion criteria (6 listed)
- Male factor infertility, tubal factor.
- Endocrineopathy
- Hypothyrodism
- Morbid obesity
- Under weight
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 |
|---|---|---|
| Letrozoleoral tablets 5 mg | Drug | Lertozole |
| Clomiphene Citrate plus N acetyl cystineClomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg | Drug | clomiphene plus N- acetyl cystiene |
Primary outcome
rate of ovulation
Time frame: 3 months
ultrasound evaluation
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 7 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole and Clomiphene Citrate plus N acetyl cystine in people with Infertility, run by Assiut University.
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 6 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 7 Aug 2017. 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. 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?
rate of ovulation (time frame: 3 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 7 Aug 2017.