Magnesium Oxide and Letrozole Versus Letrozole Alone on Ovarian Response in Insulin Resistant PCOS

NCT07766590 | Completed

• 1 other identifier: BMU-5510-Mg
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 better as ovulation induction. Experimental group will receive magnesium oxide and letrozole alone. Comparator group will receive letrozole alone.

Conditions

Insulin Resistant PCOS

Outcome Measures

Primary Outcomes (3)

• Ovulation rate

  Ovulation will be assessed by day 21 progesterone level \>3ng/ml

  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.

  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.

  From day 12 to day 14 of menstruation.

Secondary Outcomes (1)

• Pregnancy

  If missed period occur after each ovulation induction cycle for upto 12weeks

Study Arms (2)

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.

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.

Drug: Letrozole 2.5mg

Interventions

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.

Experimental arm: Magnesium oxide and letrozole

Letrozole 2.5mg DRUG

Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation

Comparator group: Letrozole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Related Links

• Related Info

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phase B Resident

Model Details: Open label parallel design randomized controlled trial

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: June 1, 2025
• Primary Completion: May 15, 2026
• Study Completion: May 28, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)