Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- number of embryos
研究概览
简要总结
The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:
Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?
Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.
Participants will:
Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger
- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing
详细描述
The goal of this novel clinical trial is to study if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles in comparison to a gold standard drug cetrorelix:
All PCOS cases: 50 case in this novel trial. 25 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.
At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.
Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.
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
- Single (Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):
- •oligo- or anovulation
- •clinical and/or biochemical signs of hyperandrogenism
- •polycystic ovaries).
- •A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.
排除标准
- •age 38 years
- •basal FSH level 12 mIU/mL
- •previous ovarian surgery
- •congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.
研究组 & 干预措施
Drospirenone
25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
干预措施: Drospirenone drug (Drug)
cetrorelix
25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day
干预措施: Cetrorelix drug (Drug)
结局指标
主要结局
number of embryos
时间窗: 5 days
number of embryos developed
number of cases to develop OHSS
时间窗: 1 week
cases that will develop OHSS
次要结局
- clinical pregnancy rate(15 days after embryo transfer)
研究者
Ahmed Saad
Professor of Obsterics & Gynecology
Benha University