Comparison of Clomiphene Citrate vs Clomiphene Citrate in Combination With Pioglitazone in Terms of Ovarian Stimulation and Pregnancy Rates Among Infertile Women Suffering From Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Ovarian stimulation rate
研究概览
简要总结
Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.
详细描述
Patients fulfilling the inclusion criteria will be enrolled and randomized using computer-generated random numbers to receive either pioglitazone 30 mg daily or a placebo starting from the second day of menstruation for a similar duration. All participants will receive clomiphene citrate 150 mg between the third and seventh days of the menstrual cycle. Transvaginal sonography will be performed on the 10th day of the menstrual cycle, and the number of large follicles (16-24 mm) will be recorded. Human chorionic gonadotropin (hCG) will be administered to patients with at least one follicle measuring 16-24 mm and an endometrial thickness of at least 7 mm, followed by intrauterine insemination (IUI). Patients will be followed until the end of the menstrual cycle, and in cases of a 5-day delay in menstruation, a blood sample will be obtained to measure β-hCG for biochemical confirmation of pregnancy. Any adverse effects observed during the treatment period, including edema, fluid retention, blurred vision, or weight gain, will be documented.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.
排除标准
- •History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease
研究组 & 干预措施
Group C
干预措施: Clomiphene Citrate. (Drug)
Group CP
干预措施: Pioglitazone (PIO) + Clomiphene citrate (Drug)
结局指标
主要结局
Ovarian stimulation rate
时间窗: 10th day of menstrual cycle
This will be determined by no. of large size follicles (16-24mm in size) recruited following treatment on 10th day of menstrual cycle using transvaginal ultrasound to measure the size and no. of follicles.
次要结局
- Pregnancy rates(5th day after end of menstrual cycle)
研究者
Kinza Azhar
Principal Investigataor
PAEC General Hospital, Islamabad
