Follicular Synchronization in Polycystic Ovarian Syndrome Patients Undergoing Intracytoplasmatic Sperm Injection With Letrozole /Antagonist Protocol: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the number of asynchronized follicles in both groups
研究概览
简要总结
The use of GnRH antagonist protocol nowadays is the slandered protocol of controlled ovarian stimulation in patients with poly cystic ovarian syndrome (PCOS) because it decreases the incidence of OHSS(1, 2). However, this protocol may lead to asynchronous growth of follicles with an early dominant follicle specially in PCOS patients(3). In most of cases this phenomenon will affect the IVF outcomes(2, 4) Aromatase inhibitors (AIs) nowadays is recommended to be used for ovulation induction in patients with PCOS (5, 6).It has fewer side effects, and a shorter half-life than clomiphene citrate(CC), and no effect ON the endometrial receptivity. It is used in treating patients with chronic anovulation, unexplained infertility and poor ovarian reserve(7). It acts through decreasing estrogen levels and allows follicle stimulating hormone (FSH) release from the hypothalamus (8, 9). It could be used alone or with combination with human menopausal gonadotropin (HMG) specially in patients with CC resistant(10-13). It also improves the ovarian response to FSH when they are used in combination and it decreases the risk of OHSS (14).
This study aims to evaluate the effect of uses of letrozole in combination with HMG during ovarian stimulation in patients having PCOS undergoing IVF/ICSI on the follicular growth pattern, synchronized growth of follicles, maturity of oocyte and the quality of embryos.
详细描述
Participants in this study will be group of subfertile women undergoing IVF/ ICSI trial and having polycystic ovarian syndrome Inclusion criteria
-
Ages ≥20 and <40 years old
-
Women having the diagnosis of polycystic ovarian syndrome according to Rotterdam criteria (15)
-
Women who have at least one of the following indications for IVF or ICSI:
-
Resistance to slandered ovulation induction and life style modification
-
Tubal factors: unilateral or bilateral tubal obstruction, unilateral or bilateral salpingectomy or tubal ligation
-
Male factors: oligoasthenozoospermia or obstructive azoospermia Exclusion criteria
-
Women with unexplained infertility. 2. women with poor ovarian reserve according to Bologna criteria (16). 3. Couples with known chromosomal abnormalities. 4. Women who refuse to participate in this study.
Methods
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blinded clinical trial
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages ≥20 and <40 years old
- •Women having the diagnosis of polycystic ovarian syndrome according to Rotterdam criteria (15)
- •Women who have at least one of the following indications for IVF or ICSI:
- •Resistance to slandered ovulation induction and life style modification
- •Tubal factors: unilateral or bilateral tubal obstruction, unilateral or bilateral salpingectomy or tubal ligation
- •Male factors: oligoasthenozoospermia or obstructive azoospermia
排除标准
- •Women with unexplained infertility.
- •women with poor ovarian reserve according to Bologna criteria (16).
- •Couples with known chromosomal abnormalities.
- •Women who refuse to participate in this study.
研究组 & 干预措施
• Study group
It contains 100 patients will undergo ovarian stimulation with letrozole 2.5mg twice daily (Femara; Novartis Pharma Services, Basel, Switzerland) for 5 days starting from the first day of menstruation in combination with low dose step up stimulation with recombinant FSH starting in the third day of menstruation.
干预措施: letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland) (Drug)
结局指标
主要结局
the number of asynchronized follicles in both groups
时间窗: 30 min
• Asynchronization will considered when there is a difference of at least 2 mm between the dominant follicle and other follicles
次要结局
未报告次要终点
研究者
Mohamed Taman
lecturer
Mansoura University Hospital