Polycystic Ovarian Syndrome (PCOS)Phase 3NCT07143682
Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
A Phase 3 study testing Letrozol step up dose and Conventional fixed dose letrozole in people with Polycystic Ovarian Syndrome (PCOS) and Infertility, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if drug letrozole in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Infertility
- What is being tested?
- Letrozol step up dose and Conventional fixed dose letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Jan 2023to 30 Jun 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS women with subfertility
- Selected for ovulation induction
Who cannot join
- Body mass index (BMI) ˂18 and ≥30 kg/m2,
- Women with other infertility factors (endometriosis, suspected tubal factor, and uterine causes of infertility)
- Male factor infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole Step up Compared to Conventional Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
The goal of this clinical trial is to learn if drug letrozole in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. The main Questions it aims to answer are:
- Does drug letrozole in step up dose result in better ovarian response?
- What medical problems do participants have when taking drug letrozole in step up dose? Researchers will compare drug letrozole step up dose to a standard low dose to see if the step up dose works to achieve better ovarian response.
Read more
Participants will:
- Take drug letrozole step up or standard low dose from day 2 of menstruation for 3 cycles
- Visit the clinic on day 12-16 of menstural cycle for checkups and tests
- Keep a diary of any untoward symptoms
Read the detailed description
Background: Polycystic ovary syndrome (PCOS) is the largest single cause of anovulatory infertility. Letrozole, an aromatase inhibitor, has been regarded as the first-line drug for ovulation induction in PCOS patients. The conventional protocol of letrozole includes the administration of a fixed dose of letrozole (2.5 -7.5 mg) for 5 days. Few recent studies have shown that the step-up letrozole protocol causes more follicles to grow, induces more ovulation, and increases the pregnancy rate. This study aimed to compare the effect of the letrozole step-up and conventional fixed-dose protocol for ovulation induction in infertile women with PCOS.
Methods: This open-label randomized controlled study was conducted on a total of 70 infertile PCOS women eligible for ovulation induction. Treatment with letrozole started from day 2-3 of menstruation or withdrawal bleeding. They were randomly allocated into two groups. The experimental group (n=35) was given step-up letrozole, one (2.5 mg), two (5 mg), three (7.5 mg), and four (10 mg) tablets, single dose sequentially for 4 days. The comparator group (n=35) received conventional fixed-dose letrozole, two (5mg) tablets daily for 5 days. The outcome variables were the number of participants having a mature follicle by day 12-16 of the cycle and the number of mature follicles on the day of trigger.
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Infertility
- Being tested
- Letrozol step up dose, Conventional fixed dose letrozole
- Keywords
- Polycystic ovary syndrome, letrozole, ovulation induction
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozol step up doseDrug
Tablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
Conventional fixed dose letrozoleDrug
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Letrozole step up | Experimental | Tab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days Receives: Drug: Letrozol step up dose |
| Conventional fixed dose letrozole | Active comparator | Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle Receives: Drug: Conventional fixed dose letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants having mature follicle (mean diameter ≥18mm)
The number of participants having mature follicle (mean diameter ≥18mm) on day 12 to 16 of the cycle
Measured: 3 months
The number of participants having adequate endometrial thickness ( 7mm or more)
The number of participants having adequate endometrial thickness ( 7mm or more) on the day of trigger
Measured: 3 months
Secondary outcomes (1)
Pregnancy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start8 Jan 2023
- Primary completion24 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143682
- Sponsor's protocol ID
- 4286
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaur J, Suri V, Gainder S, Arora A. Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility. Arch Gynecol Obstet. 2019 Dec;300(6):1767-1771. doi: 10.1007/s00404-019-05326-2. Epub 2019 Oct 20.
PubMed 31631248
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Step up Compared to Conventional Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07143682
- Acronym / sponsor ID
- 4286
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Infertility
- Keywords
- Polycystic ovary syndrome, letrozole, ovulation induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Aug 2025 (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 goal of this clinical trial is to learn if drug letrozole in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. The main Questions it aims to answer are:
- Does drug letrozole in step up dose result in better ovarian response?
- What medical problems do participants have when taking drug letrozole in step up dose? Researchers will compare drug letrozole step up dose to a standard low dose to see if the step up dose works to achieve better ovarian response.
Participants will:
- Take drug letrozole step up or standard low dose from day 2 of menstruation for 3 cycles
- Visit the clinic on day 12-16 of menstural cycle for checkups and tests
- Keep a diary of any untoward symptoms
Detailed description
Background: Polycystic ovary syndrome (PCOS) is the largest single cause of anovulatory infertility. Letrozole, an aromatase inhibitor, has been regarded as the first-line drug for ovulation induction in PCOS patients. The conventional protocol of letrozole includes the administration of a fixed dose of letrozole (2.5 -7.5 mg) for 5 days. Few recent studies have shown that the step-up letrozole protocol causes more follicles to grow, induces more ovulation, and increases the pregnancy rate. This study aimed to compare the effect of the letrozole step-up and conventional fixed-dose protocol for ovulation induction in infertile women with PCOS.
Methods: This open-label randomized controlled study was conducted on a total of 70 infertile PCOS women eligible for ovulation induction. Treatment with letrozole started from day 2-3 of menstruation or withdrawal bleeding. They were randomly allocated into two groups. The experimental group (n=35) was given step-up letrozole, one (2.5 mg), two (5 mg), three (7.5 mg), and four (10 mg) tablets, single dose sequentially for 4 days. The comparator group (n=35) received conventional fixed-dose letrozole, two (5mg) tablets daily for 5 days. The outcome variables were the number of participants having a mature follicle by day 12-16 of the cycle and the number of mature follicles on the day of trigger.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole step up | Experimental | Drug: Letrozol step up doseTab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days |
| Conventional fixed dose letrozole | Active comparator | Drug: Conventional fixed dose letrozoleTab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCOS women with subfertility
- Selected for ovulation induction
Key exclusion criteria (3 listed)
- Body mass index (BMI) ˂18 and ≥30 kg/m2,
- Women with other infertility factors (endometriosis, suspected tubal factor, and uterine causes of infertility)
- Male 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 |
|---|---|---|
| Letrozol step up doseTablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days | Drug | Letrozole step up |
| Conventional fixed dose letrozoleTab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle | Drug | Conventional fixed dose letrozole |
Primary outcome
The number of participants having mature follicle (mean diameter ≥18mm)
Time frame: 3 months
The number of participants having mature follicle (mean diameter ≥18mm) on day 12 to 16 of the cycle
The number of participants having adequate endometrial thickness ( 7mm or more)
Time frame: 3 months
The number of participants having adequate endometrial thickness ( 7mm or more) on the day of trigger
1 secondary outcome
Pregnancy
Time frame: 4 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 16 Dec 2025.
- Background: PubMed 31631248Kaur J, Suri V, Gainder S, Arora A. Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility. Arch Gynecol Obstet. 2019 Dec;300(6):1767-1771. doi: 10.1007/s00404-019-05326-2. Epub 2019 Oct 20.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozol step up dose and Conventional fixed dose letrozole in people with Polycystic Ovarian Syndrome (PCOS) and Infertility, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 3 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 16 Dec 2025. 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 Bangladesh. 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 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?
The number of participants having mature follicle (mean diameter ≥18mm) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143682, which also lists 1 linked publication.
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 16 Dec 2025.