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

Overview

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.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes