Progesterone Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist in Women with Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved (ovarian response).
研究概览
简要总结
The purpose of this study is to compare the use of the progesterone-primed ovarian stimulation protocol versus GnRH antagonist protocol in women with polycystic ovarian syndrome (PCOS) regarding the number of oocytes retrieved, percentage of MII oocytes, and the rate of good quality blastocysts available for cryopreservation.
详细描述
The syndrome of polycystic ovary (PCOS) is a common endocrine disease. It accounts for about 80% of women with anovulatory infertility. In vitro fertilization (IVF) is a commonly used infertility treatment for PCOS patients who fail to conceive with ovulation induction or if there are concomitant infertility factors such as tubal damage or male subfertility.
Patients with polycystic ovary syndrome (PCOS) are at high risk of ovarian hyperstimulation syndrome (OHSS) during in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) treatment which may lead to cycle cancellation to prevent their high morbidity or death rates. Increasing evidence has confirmed that frozen embryo transfer (FET) is related to a lower risk of OHSS. The 'freeze-all' strategy is recommended for PCOS patients to reduce the potential of moderate/severe OHSS.
Controlled ovarian stimulation (COS) is a key step in assisted reproductive technology (ART). In addition to the use of gonadotropins to recruit multiple follicles, it is mandatory to use a drug to prevent luteinizing hormone (LH) surge and premature ovulation.
Early LH surge is a main cause of cycle cancellation during controlled ovarian stimulation (COH) for women receiving IVF/ICSI therapy. The release of LH causes ovulation in response to rapidly increasing levels of E2 in the normal cycle, and a premature LH increase may impair IVF/ICSI egg production.
Gonadotropin-releasing hormone (GnRH) antagonist protocol has emerged as a routine ovulation stimulation protocol in recent decades due to its comparable convenience, safety, and efficacy compared to GnRH agonists. GnRH antagonist protocol is now the most commonly used COS protocol in PCOS patients due to the significantly reduced risk of OHSS especially when gonadotropin-releasing hormone agonist (GnRHa) was used for ovulation trigger. The GnRH antagonists were used primarily to reduce the incidence of the early LH surge. However, GnRH antagonists are expensive and sometimes difficult to manage with high rates of cycle cancellation and premature LH surges.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 37 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age <37 years.
- •Body mass index (BMI) between (≥18 kg/m2 and ≤35 kg/m2).
- •Polycystic ovarian syndrome patients (according to Rotterdam criteria).
- •Patients suffering from primary or secondary infertility who are candidates for ICSI.
排除标准
- •Uncorrected Uterine factor of infertility: intrauterine adhesions, submucosal fibroids, and septate uterus.
- •Severe male factor infertility
研究组 & 干预措施
Progesterone-primed ovarian stimulation Group
• A daily dose of 20 mg dydrogesterone (2 Duphastone 10 mg tablets) will be added from day 1 or 2 of the menstrual cycle and will be continued till the day of the GnRH agonist trigger.
干预措施: Progesterone (Drug)
Antagonist protocol
• GnRH antagonist (Cetrotide 0.25 mg) subcutaneous injection will be added daily from the 6th day of ovarian stimulation and will be continued till the day of the GnRH agonist trigger.
干预措施: GnRH antagonist (Cetrorelix) (Drug)
结局指标
主要结局
Number of oocytes retrieved (ovarian response).
时间窗: Baseline
Total number of oocytes retrieved (in both groups)
Percentage of MII oocytes.
时间窗: Baseline
Number of MII oocytes to the total number of oocytes retrieved (in both groups)
Rate of good-quality blastocysts available for cryopreservation
时间窗: Baseline
percentage of the number of good-quality blastocysts to the number of 2PN fertilized oocytes cultured
次要结局
- Fertilization rate(Baseline)
- Rate of blastocyst formation(Baseline)
- Clinical pregnancy rate after 1st FET(Baseline)
研究者
Aly Hussein
Principle investigator
El Shatby University Hospital for Obstetrics and Gynecology
