PCOSPCOS OIDNCT07759518
Letrozole High Dose (10 mg) Compared to Letrozole Low Dose( 5 mg) for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome
A study testing Tab.Letrozole 10 mg for 5 days and Tab.Letrozole 5mg for 5 days in people with PCOS, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if drug letrozole 10mg for 5 days works better than letrozole 5mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Tab.Letrozole 10 mg for 5 days and Tab.Letrozole 5mg for 5 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2025to 1 Feb 2026
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-35 years old
- BMI : 18-30 kg/m2
- Diagnosed cases of PCOS patients according to Rotterdam criteria.
- Corrected hypothyroidism and hyperprolactinemia
Who cannot join
- Women with other infertility factors (endometriosis, tubal and uterine causes of infertility)
- Male factor infertility
- Impaired hepatic or renal function
- History of hypersensitivity to letrozole
- -
- -
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if drug letrozole 10mg for 5 days works better than letrozole 5mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are:
What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 10mg for 5 days works better than letrozole 5 mg for 5 days for ovarian stimulation in infertile women with PCOS
Read more
Participants will:
The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle
Read the detailed description
Atotal number of 86 eligible PCOS women will be randomized to either letrozole 10 mg for 5 days or letrozole 5 mg for 5 days for ovulation induction. The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg for 5 days (Tab letrol 2.5mg -Renata Pharmaceutical. Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle.The presence of preovulatory follicle, multifollicular development, the number of developing follicles, size of largest follicle and endometrial thickness with pattern will be assessed. The woman will then be advised to test for LH surge by urinary LH kit daily until positive and when positive will have intercourse for two days. She will have serum progesterone estimation after 7 days. She will repeat same dose of ovulation induction if she has menstruation and if there are no symptoms of side effect regarding letrozole intake or will do pregnancy test if she misses period. If missed period occurs further visit will be required for serum β-hCG estimation for confirmation of pregnancy. If pregnancy test is positive she will do an USG for fetal cardiac motion around 7-8 weeks.If B-hCG negative I will give the woman Tab. Norethisterone (5mg) (Tab. Normens 5mg - Renata pharmaceuticals) for (7-10) days for withdrawal bleeding. After withdrawal bleeding I will give her previous dose letrozole. In that situation she will define as a case of anovulation. If cyst appears I will do a Transvaginal sonography of that woman in D2 of the cycle to observe the cyst. If cyst persist, I will hold stimulation in that cycle. If cyst disappear I will give stimulation. All subject will receive drugs (Tab. Letrol 2.5mg, Tab. Normens 5mg) from me. I will ensure their proper intake by cell phone and during their visit they will show their blank strip of drug for confirmation. The cumulative data will be subjected to analysis. by Statistical Package for Social Sciences version 27 for Windows (SPSS Inc., Chicago, Illinois, USA).
- Conditions
- PCOS
- Being tested
- Tab.Letrozole 10 mg for 5 days, Tab.Letrozole 5mg for 5 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab.Letrozole 10 mg for 5 daysDrug
Tablet letrozole 10mg for 5 days from day 2-3 of enstruation/withdrawal bleeding (10mg in divided dose-5mg in morning \& 5mg at bed time for 5 days) for three months
Tab.Letrozole 5mg for 5 daysDrug
Tab letrozole 5mg for 5 days from day 2-3 ofenstruation/withdrawal bleeding (5mg at bed time for 5 days) for three months.
| Study group | Role | What they receive |
|---|---|---|
| Tab.Letrozole 10 mg for 5 days | Experimental | Tab letrozole 10 mg for 5 days from day 2-3 of menstruation/withdrawal bleeding (5mg at morning and 5mg bed time for 5 days) for 3 cycle Receives: Drug: Tab.Letrozole 10 mg for 5 days |
| Tab.Letrozole 5 mg for 5 days | Active comparator | Tab letrozole 5mg for 5 days from day 2-3 of enstruation/withdrawal bleeding ( 5mg at bed time for 5 days) for three cycle Receives: Drug: Tab.Letrozole 5mg for 5 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of preovulatory follicle
Preovulatory follicle:A follicle14 mm or more
Measured: 12 weeks
Multifollicular development
Multifollicular development: Presence of more than one preovulatory follicle
Measured: 12 weeks
Secondary outcomes (4)
Ovulation Rate
Ovulation:Ovulation will be diagnosed by presence of any one of following • Detecting LH surge in ovulation predictor kit • Day 21 progesterone level ≥ 3 ng/dl • An appropriately timed menses in previously oligomenorrheic patient • A positive pregnancy test
Measured: 3 months
Pregnancy rate
Pregnancy: Pregnancy will be determined after missed period by serum β-hCG estimation. Serum β-hCG> 5 mIU/mL is diagnosed as pregnancy [ Atellica integrated clinical chemistry and immunoassay analyzer] followed by the presence of fetal cardiac motion on ultrasound around 7-8wk
Measured: 3 months
Number of developing follicles
Developing follicle:Follicles with mean diameter between 10-13 mm
Measured: 3 months
Days to LH surge
Days to LH surge: The number of days from the first dose of letrozole to LH surge determined by ovulation predictor kit.
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 posted12 Aug 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Shakeela Ishrat, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759518
- Sponsor's protocol ID
- 5395
- Acronym
- PCOS OID
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mandelbaum RS, Agarwal R, Melville S, Violette CJ, Winer S, Shoupe D, Matsuo K, Paulson RJ, Quinn MM. A comparison of letrozole regimens for ovulation induction in women with polycystic ovary syndrome. F S Rep. 2024 Mar 28;5(2):170-175. doi: 10.1016/j.xfre.2024.03.004. eCollection 2024 Jun.
PubMed 38983726Ramezanzadeh F, Nasiri R, Sarafraz Yazdi M, Baghrei M. A randomized trial of ovulation induction with two different doses of Letrozole in women with PCOS. Arch Gynecol Obstet. 2011 Oct;284(4):1029-34. doi: 10.1007/s00404-011-1951-5. Epub 2011 Jul 7.
PubMed 21735192
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole High Dose (10 mg) Compared to Letrozole Low Dose( 5 mg) for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07759518
- Acronym / sponsor ID
- PCOS OID / 5395
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 12 Aug 2026 (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 10mg for 5 days works better than letrozole 5mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are:
What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 10mg for 5 days works better than letrozole 5 mg for 5 days for ovarian stimulation in infertile women with PCOS
Participants will:
The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle
Detailed description
Atotal number of 86 eligible PCOS women will be randomized to either letrozole 10 mg for 5 days or letrozole 5 mg for 5 days for ovulation induction. The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg for 5 days (Tab letrol 2.5mg -Renata Pharmaceutical. Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle.The presence of preovulatory follicle, multifollicular development, the number of developing follicles, size of largest follicle and endometrial thickness with pattern will be assessed. The woman will then be advised to test for LH surge by urinary LH kit daily until positive and when positive will have intercourse for two days. She will have serum progesterone estimation after 7 days. She will repeat same dose of ovulation induction if she has menstruation and if there are no symptoms of side effect regarding letrozole intake or will do pregnancy test if she misses period. If missed period occurs further visit will be required for serum β-hCG estimation for confirmation of pregnancy. If pregnancy test is positive she will do an USG for fetal cardiac motion around 7-8 weeks.If B-hCG negative I will give the woman Tab. Norethisterone (5mg) (Tab. Normens 5mg - Renata pharmaceuticals) for (7-10) days for withdrawal bleeding. After withdrawal bleeding I will give her previous dose letrozole. In that situation she will define as a case of anovulation. If cyst appears I will do a Transvaginal sonography of that woman in D2 of the cycle to observe the cyst. If cyst persist, I will hold stimulation in that cycle. If cyst disappear I will give stimulation. All subject will receive drugs (Tab. Letrol 2.5mg, Tab. Normens 5mg) from me. I will ensure their proper intake by cell phone and during their visit they will show their blank strip of drug for confirmation. The cumulative data will be subjected to analysis. by Statistical Package for Social Sciences version 27 for Windows (SPSS Inc., Chicago, Illinois, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tab.Letrozole 10 mg for 5 days | Experimental | Drug: Tab.Letrozole 10 mg for 5 daysTab letrozole 10 mg for 5 days from day 2-3 of menstruation/withdrawal bleeding (5mg at morning and 5mg bed time for 5 days) for 3 cycle |
| Tab.Letrozole 5 mg for 5 days | Active comparator | Drug: Tab.Letrozole 5mg for 5 daysTab letrozole 5mg for 5 days from day 2-3 of enstruation/withdrawal bleeding ( 5mg at bed time for 5 days) for three cycle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-35 years old
- BMI : 18-30 kg/m2
- Diagnosed cases of PCOS patients according to Rotterdam criteria.
- Corrected hypothyroidism and hyperprolactinemia
Key exclusion criteria (6 listed)
- Women with other infertility factors (endometriosis, tubal and uterine causes of infertility)
- Male factor infertility
- Impaired hepatic or renal function
- History of hypersensitivity to letrozole
- -
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 |
|---|---|---|
| Tab.Letrozole 10 mg for 5 daysTablet letrozole 10mg for 5 days from day 2-3 of enstruation/withdrawal bleeding (10mg in divided dose-5mg in morning \& 5mg at bed time for 5 days) for three months | Drug | Tab.Letrozole 10 mg for 5 days |
| Tab.Letrozole 5mg for 5 daysTab letrozole 5mg for 5 days from day 2-3 ofenstruation/withdrawal bleeding (5mg at bed time for 5 days) for three months. | Drug | Tab.Letrozole 5 mg for 5 days |
Primary outcome
Presence of preovulatory follicle
Time frame: 12 weeks
Preovulatory follicle:A follicle14 mm or more
Multifollicular development
Time frame: 12 weeks
Multifollicular development: Presence of more than one preovulatory follicle
4 secondary outcomes
Ovulation Rate
Time frame: 3 months
Pregnancy rate
Time frame: 3 months
Number of developing follicles
Time frame: 3 months
Days to LH surge
Time frame: 3 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 12 Aug 2026.
- Results publication: PubMed 38983726Mandelbaum RS, Agarwal R, Melville S, Violette CJ, Winer S, Shoupe D, Matsuo K, Paulson RJ, Quinn MM. A comparison of letrozole regimens for ovulation induction in women with polycystic ovary syndrome. F S Rep. 2024 Mar 28;5(2):170-175. doi: 10.1016/j.xfre.2024.03.004. eCollection 2024 Jun.
- Results publication: PubMed 21735192Ramezanzadeh F, Nasiri R, Sarafraz Yazdi M, Baghrei M. A randomized trial of ovulation induction with two different doses of Letrozole in women with PCOS. Arch Gynecol Obstet. 2011 Oct;284(4):1029-34. doi: 10.1007/s00404-011-1951-5. Epub 2011 Jul 7.
- 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.
Shakeela Ishrat study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tab.Letrozole 10 mg for 5 days and Tab.Letrozole 5mg for 5 days in people with PCOS, run by Mst.Sumyara Khatun 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 4 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 12 Aug 2026. 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.
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?
Presence of preovulatory follicle (time frame: 12 weeks). 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 NCT07759518, which also lists 2 linked publications.
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 12 Aug 2026.