Insulin Resistant PCOS
Conditions
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.
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.
Interventions
DRUGExperimental 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.
DRUGLetrozole 2.5mg
Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label parallel design randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | Assessed on 21st day of menstruation | Ovulation will be assessed by day 21 progesterone level \>3ng/ml |
| Proportion of patients developing mature follicle | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | If missed period occur after each ovulation induction cycle for upto 12weeks | Pregnancy will be determined by serum beta HCG. |
Countries
Bangladesh
Outcome results
None listed