Infertility Poly Cystic OvaryNCT03181919
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
A study testing Letrozole in people with Infertility Poly Cystic Ovary, run by Benha University.
Trial summary
the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility Poly Cystic Ovary
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2017
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20 -37 years old.
- No conception for at least one year.
- Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.
Who cannot join
- Age < 20 and > 35 years old.
- Uterine pathology e.g. fibroid or ovarian cyst.
- Hyperprolactinemia, hypo or hyperthyroidism.
- Impaired hepatic or renal function.
- History of hypersensitivity to study drugs.
About this study
the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS
Read the detailed description
The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos .
Sample size determination:
Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.
Sample size was calculated by PASS 11 Computer program for sample size calculation.
Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II.
Patients were divided into two groups with randomization sheet:
Group (I): includes 45 females taking Letrozole (old regimen).
Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).
- Conditions
- Infertility Poly Cystic Ovary
- Being tested
- Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
| Study group | Role | What they receive |
|---|---|---|
| Step Up group | Experimental | includes females taking Letrozole 5 mg tablets in a step-up protocol 5 mg in day one, 7.5 in day 2, 10 mg in days 3, 12.5 mg in day 4 and 15 in day 5 started in day 3 to day 7 of menstrual cycle. Receives: Drug: Letrozole |
| Control group | No intervention | includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature follicles
Measured: 2 weeks
Secondary outcomes (1)
Pregnancy rate
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Poly Cystic OvaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abou Bakr Mohamed El Nashaar, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181919
- Sponsor's protocol ID
- letrozole step-up protocol
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish a manuscript
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
- ClinicalTrials.gov ID
- NCT03181919
- Acronym / sponsor ID
- letrozole step-up protocol
- Conditions
- Infertility Poly Cystic Ovary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 9 Jun 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.
the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS
Detailed description
The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos .
Sample size determination:
Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.
Sample size was calculated by PASS 11 Computer program for sample size calculation.
Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II.
Patients were divided into two groups with randomization sheet:
Group (I): includes 45 females taking Letrozole (old regimen).
Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Up group | Experimental | Drug: Letrozoleincludes females taking Letrozole 5 mg tablets in a step-up protocol 5 mg in day one, 7.5 in day 2, 10 mg in days 3, 12.5 mg in day 4 and 15 in day 5 started in day 3 to day 7 of menstrual cycle. |
| Control group | No intervention | –includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20 -37 years old.
- No conception for at least one year.
- Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.
Key exclusion criteria (5 listed)
- Age < 20 and > 35 years old.
- Uterine pathology e.g. fibroid or ovarian cyst.
- Hyperprolactinemia, hypo or hyperthyroidism.
- Impaired hepatic or renal function.
- History of hypersensitivity to study drugs.
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 |
|---|---|---|
| LetrozoleLetrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation. | Drug | Step Up group |
Primary outcome
Number of mature follicles
Time frame: 2 weeks
1 secondary outcome
Pregnancy rate
Time frame: one month
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 9 Jun 2017.
- Individual participant dataSharing planned: Yes. Publish a manuscript
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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 study testing Letrozole in people with Infertility Poly Cystic Ovary, run by Benha 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 3 inclusion and 5 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 9 Jun 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.
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?
Number of mature follicles (time frame: 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 9 Jun 2017.