An interventional study of Experimental drug: Magnesium oxide (365 mg) and Letrozole 2.5mg in Insulin Resistant PCOS, sponsored by Bangladesh Medical University. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
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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.
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.
Bangladesh Medical University is the lead sponsor of 44 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Male factor
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 drug: Magnesium oxide (365 mg)
Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation.
Drug: Letrozole 2.5mg
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.
Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation
Ovulation rate
Ovulation will be assessed by day 21 progesterone level \>3ng/ml
Time frame: 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.
Time frame: 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.
Time frame: From day 12 to day 14 of menstruation.
Pregnancy
Pregnancy will be determined by serum beta HCG.
Time frame: If missed period occur after each ovulation induction cycle for upto 12weeks
Plan to share: No
Ran from Jun 2025 to primary completion in May 2026, 11 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Oxide
Bangladesh Medical University