Cabergoline and Letrozole Compared to Letrozole Alone for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Ovulation Rate
研究概览
简要总结
Does combined Cabergoline and letrozole increase ovulation rate What medical problems do participants have when taking drug Cabergoline and Letrozole ? Researchers will compare drug combination of Cabergoline and letrozole to letrozole alone to see combined cabergoline and letrozole works better as ovulation induction.
Participants will:
experimental group will receive Cabergoline and Letrozole comparator group will receive letrozole alone TVS Monitoring will be done for 3 cycle for ovarian response
详细描述
After obtaining approval of Institutional Review Board, this RCT will be conducted. Women with polycystic ovary syndrome wants fertility, attending the OPD of Reproductive Endocrinology and Infertility department at BMU will be the study population.
After fulfilling the inclusion and exclusion criteria participants will be allocated to experimental group ( group A : combined cabergoline and letrozole) or comparator group( group B : letrozole only). Randomization will be done between group A and group B. The random sequence generation will be done by permuted blocks randomized with computer generated random numbers. Allocation concealment will be done by serially numbered opaque sealed envelope. Each envelop will be labeled with a serial number and will have a card inside noting the intervention type. Allocation will never be changed after opening the closed envelops.
First Cycle :
Purpose and procedure of study will be discussed with the participant and informed written consent (Appendix II) will be obtained to participate in the study. Detailed socio-demographic data, history, clinical examination and investigations will be recorded in a predesigned data sheet.
Treatment will be started from the 2nd day of menstruation/withdrawal bleeding after the baseline visit and investigations. Experimental group participants will receive tab cabergoline 0.5 mg (1 tablet at night) on day 2 and day 9 of cycle plus letrozole 5 mg/day ( 2 tablet at night)for consecutive 5 days starting from the day 2 of menstrual cycle or withdrawal bleeding. Participants in the comparator group will receive only letrozole 5 mg/day (2 tablet at night) for consecutive 5 days starting from the day 2 of menstrual cycle or withdrawal bleeding. All participants will be instructed not to take any medications during the trial except after consultation with primary investigator.
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
- •PCOS patients diagnosed according to Rotterdam criteria.
- •Age: 18-35 years.
- •Primary or secondary subfertility.
- •Selected for ovulation induction.
排除标准
- •Women suffered from PCOS like symptom ex. Late onset congenital adrenal hyperplasia, Cushing syndrome.
- •Serum prolactin (more than 50 ng/ml) (Kyritsi et al., 2018).
- •Male factor infertility.
- •Women with other infertility factors (endometriosis, PID,uterine & tubal causes of infertility).
- •Uncontrolled Medical disease (DM, HTN, kidney disease, liver disease).
- •History of hypersensitivity to cabergoline & letrozole.
- •Thyroid dysfunction ( serum TSH ≥5mIU/L)
- •BMI:< 18.5 kg/m2 and ≥30 kg/m
- •Patients on metformin therapy.
- •Patient on antiemetic like Domperidone metoclopramide, antipsychotic drug like haloperidol and risperidone, tricyclic antidepressant like amitriptyline, clomipramine, antihypertensive like verapamil, methyldopa, reserpine.
研究组 & 干预措施
Experimental arm : Cabergoline and letrozole
participants will receive Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
干预措施: Cabergoline 0.5 mg (Combination Product)
Comparator arm : letrozole
participants will receive Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
干预措施: Letrozole 0.5mg (Drug)
结局指标
主要结局
Ovulation Rate
时间窗: Assessed within 21 days after each ovulation induction cycle for upto 12 weeks
Ovulation will be diagnosed by presence of any one of following(Mandelbaum et al., 2024) * LH surge in ovulation predictor kit * Day 21 progesterone level ≥ 3 ng/dl * An appropriately timed menses in previously oligomenorrheic women * A positive pregnancy test
次要结局
- Presence of preovulatory follicle on D12 of cycle(assessed by TVS within 12 days after each ovulation induction cycle ,upto 12 weeks)
- Largest follicle size on D12 of cycle(Assessed by TVS,within 12 days of each ovulation induction cycle ,upto 12 weeks)
- Pregnancy(assessed if missed period occur after each ovulation induction cycle ,for upto 12 weeks)
研究者
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University