Insulin Resistant PCOSNCT07766590
Magnesium Oxide and Letrozole Versus Letrozole Alone on Ovarian Response in Insulin Resistant PCOS
A study testing Experimental drug: Magnesium oxide (365 mg) and Letrozole 2.5mg in people with Insulin Resistant PCOS, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Does pretreatment with magnesium oxide followed by letrozole increase ovulation rate? What medical problems do participants have when taking drug magnesium oxide and letrozole? Researchers will compare magnesium oxide and letrozole to letrozole alone to see pretreatment with magnesium oxide followed by letrozole works… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Insulin Resistant PCOS
- What is being tested?
- Experimental drug: Magnesium oxide (365 mg) and Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2025to 28 May 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
- All PCOS patients who fulfill the Rotterdam diagnostic criteria
- Primary or secondary subfertility
- Women of age: 18-35yr
- Insulin resistance (HOMA-IR>2) (Hydrie et al.,2012)
Who cannot join
- Male factor
- Uterine, tubal and endometrial factor
- Pelvic inflammatory disease
- Patient with other endocrine disease like hypothyroidism, hyperthyroidism, congenital adrenal hyperplasia, Diabetes mellitus and hyperprolactinemia.
- BMI less than 18.5 or more than 30.
- Known allergy to magnesium oxide
- Any medication in the last 3 months which would affect insulin resistance (metformin, myoinositol)
- Conditions with a high risk for hypomagnesemia such as using diuretics, alcoholism, persistent diarrhoea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pretreatment With Magnesium Oxide Followed by Letrozole on Ovarian Response in Subfertile Women With Insulin Resistant Polycystic Ovarian Syndrome in Comparison to Letrozole Alone
Does pretreatment with magnesium oxide followed by letrozole increase ovulation rate? What medical problems do participants have when taking drug magnesium oxide and letrozole? Researchers will compare magnesium oxide and letrozole to letrozole alone to see pretreatment with magnesium oxide followed by letrozole works better as ovulation induction.
Experimental group will receive magnesium oxide and letrozole alone. Comparator group will receive letrozole alone.
Read the detailed description
After obtaining approval of Institutional Review Board, this Randomized controlled study will be conducted at Bangladesh Medical University (BMU). Infertile women with PCOS (according to Rotterdam criteria) attending the OPD of Reproductive Endocrinology and Infertility Department at BMU and fulfilling inclusion and exclusion criteria was approached for enrollment into the study. The patients will be explained in detail regarding the objectives, rationality, potential benefits and procedures of the study. The patients will be counselled regarding the drugs and unexpected side-effects. An informed written consent will be taken if they gave consent. Eligible women will be grouped to either Group A (Letrozole and magnesium group) and Group B (letrozole group) on the basis of permuted block randomization. A full assessment included demographic information (including age, parity, type of infertility) and after baseline transvaginal sonography will be done. In group A all patients will be given Tab Magnesium oxide 365mg twice daily for 3months followed by Tab Letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. In group B patients will be given Tab Letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. Then patients will be followed up by transvaginal sonography on 12th day of menstruation for follicular maturation and endometrial thickness in the REI Department of BMU. Then inj HCG (5000IU) will be given intramuscularly when at least one follicle measured 18mm.Timed intercourse will be advised every other day for 1week after inj HCG administration. On the 21st day of menstruation, serum progesterone level will be measured at Biochemistry Department of BMU. Patients will be followed up until the next cycle for conception. If conception occurs, the patients will be excluded from the study. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles. All the data will be collected for statistical analysis. If any adverse effects of Letrozole and magnesium and Letrozole alone develop then patient will be managed according to severity and situation.
- Conditions
- Insulin Resistant PCOS
- Being tested
- Experimental drug: Magnesium oxide (365 mg), Letrozole 2.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drug: Magnesium oxide (365 mg)Drug
Participants will receive tab magnesium oxide 365mg twice daily for 3months followed by tab letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation.
Letrozole 2.5mgDrug
Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Magnesium oxide and letrozole | Experimental | Participants will receive tab magnesium oxide 365mg twice daily for 3months followed by tab letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. Receives: Drug: Experimental drug: Magnesium oxide (365 mg) |
| Comparator group: Letrozole | Active comparator | Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation. Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Ovulation will be assessed by day 21 progesterone level >3ng/ml
Measured: Assessed on 21st day of menstruation
Proportion of patients developing mature follicle
Mature follicle is assessed by transvaginal sonography done on day 12 to day 14 of menstruation.Mature follicle is defined as follicles having mean diameter 18-25mm.
Measured: Day 12 to day 14 of menstruation
Proportion of patients developing endometrial thickness more than 7mm
Endometrial thickness more than 7mm is suggestive of expected ovarian response.It will be measured by transvaginal sonography.
Measured: From day 12 to day 14 of menstruation.
Secondary outcomes (1)
Pregnancy
Pregnancy will be determined by serum beta HCG.
Measured: If missed period occur after each ovulation induction cycle for upto 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jun 2025
- Primary completion15 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistant 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
- Model description
- Open label parallel design randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayeeda Farzana, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766590
- Sponsor's protocol ID
- BMU-5510-Mg
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pretreatment With Magnesium Oxide Followed by Letrozole on Ovarian Response in Subfertile Women With Insulin Resistant Polycystic Ovarian Syndrome in Comparison to Letrozole Alone
- ClinicalTrials.gov ID
- NCT07766590
- Acronym / sponsor ID
- BMU-5510-Mg
- Conditions
- Insulin Resistant PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 14 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.
Does pretreatment with magnesium oxide followed by letrozole increase ovulation rate? What medical problems do participants have when taking drug magnesium oxide and letrozole? Researchers will compare magnesium oxide and letrozole to letrozole alone to see pretreatment with magnesium oxide followed by letrozole works better as ovulation induction.
Experimental group will receive magnesium oxide and letrozole alone. Comparator group will receive letrozole alone.
Detailed description
After obtaining approval of Institutional Review Board, this Randomized controlled study will be conducted at Bangladesh Medical University (BMU). Infertile women with PCOS (according to Rotterdam criteria) attending the OPD of Reproductive Endocrinology and Infertility Department at BMU and fulfilling inclusion and exclusion criteria was approached for enrollment into the study. The patients will be explained in detail regarding the objectives, rationality, potential benefits and procedures of the study. The patients will be counselled regarding the drugs and unexpected side-effects. An informed written consent will be taken if they gave consent. Eligible women will be grouped to either Group A (Letrozole and magnesium group) and Group B (letrozole group) on the basis of permuted block randomization. A full assessment included demographic information (including age, parity, type of infertility) and after baseline transvaginal sonography will be done. In group A all patients will be given Tab Magnesium oxide 365mg twice daily for 3months followed by Tab Letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. In group B patients will be given Tab Letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. Then patients will be followed up by transvaginal sonography on 12th day of menstruation for follicular maturation and endometrial thickness in the REI Department of BMU. Then inj HCG (5000IU) will be given intramuscularly when at least one follicle measured 18mm.Timed intercourse will be advised every other day for 1week after inj HCG administration. On the 21st day of menstruation, serum progesterone level will be measured at Biochemistry Department of BMU. Patients will be followed up until the next cycle for conception. If conception occurs, the patients will be excluded from the study. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles. All the data will be collected for statistical analysis. If any adverse effects of Letrozole and magnesium and Letrozole alone develop then patient will be managed according to severity and situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label parallel design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Magnesium oxide and letrozole | Experimental | Drug: Experimental drug: Magnesium oxide (365 mg)Participants will receive tab magnesium oxide 365mg twice daily for 3months followed by tab letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. |
| Comparator group: Letrozole | Active comparator | Drug: Letrozole 2.5mgParticipants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All PCOS patients who fulfill the Rotterdam diagnostic criteria
- Primary or secondary subfertility
- Women of age: 18-35yr
- Insulin resistance (HOMA-IR>2) (Hydrie et al.,2012)
Key exclusion criteria (8 listed)
- Male factor
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 |
|---|---|---|
| Experimental drug: Magnesium oxide (365 mg)Participants will receive tab magnesium oxide 365mg twice daily for 3months followed by tab letrozole 2.5mg 3 tablets daily at night from 2nd to 6th day of menstruation. | Drug | Experimental arm: Magnesium oxide and letrozole |
| Letrozole 2.5mgParticipants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation | Drug | Comparator group: Letrozole |
Primary outcome
Ovulation rate
Time frame: Assessed on 21st day of menstruation
Ovulation will be assessed by day 21 progesterone level >3ng/ml
Proportion of patients developing mature follicle
Time frame: Day 12 to day 14 of menstruation
Mature follicle is assessed by transvaginal sonography done on day 12 to day 14 of menstruation.Mature follicle is defined as follicles having mean diameter 18-25mm.
Proportion of patients developing endometrial thickness more than 7mm
Time frame: From day 12 to day 14 of menstruation.
Endometrial thickness more than 7mm is suggestive of expected ovarian response.It will be measured by transvaginal sonography.
1 secondary outcome
Pregnancy
Time frame: If missed period occur after each ovulation induction cycle for upto 12weeks
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 14 Aug 2026.
- Related InfoLink provided by the sponsor.
- 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 study testing Experimental drug: Magnesium oxide (365 mg) and Letrozole 2.5mg in people with Insulin Resistant PCOS, run by Bangladesh Medical University 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 8 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 14 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?
Ovulation rate (time frame: Assessed on 21st day of menstruation). The study lists 3 primary outcomes in all. 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 14 Aug 2026.