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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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.
研究组 & 干预措施
Experimental arm: Magnesium oxide and letrozole
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.
干预措施: Experimental drug: Magnesium oxide (365 mg) (Drug)
Comparator group: Letrozole
Participants will receive 2.5mg of letrozole, 3 tablets at night from 2nd to 6th day of menstruation.
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
Ovulation rate
时间窗: Assessed on 21st day of menstruation
Ovulation will be assessed by day 21 progesterone level \>3ng/ml
Proportion of patients developing mature follicle
时间窗: 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
时间窗: 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.
次要结局
- Pregnancy(If missed period occur after each ovulation induction cycle for upto 12weeks)
研究者
Sayeeda Farzana
Phase B Resident
Bangladesh Medical University