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临床试验/NCT02190006
NCT02190006Unknown不适用

Comparison Between the Role of Follicular Output Rate and Preovulatory Count in the Prediction of Pregnancy in Women With Polycystic Ovarian Syndrome Undergoing Intra Cytoplasmic Sperm Injection (ICSI)

Cairo University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
clinical pregnancy

研究概览

简要总结

Our study is observational, we are observing data from routine measurements during IVF/ICSI. Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI and preovulatory count which are calculated by observing routine measurements during the IVF/ICSI procedure.

300 women with polycystic ovarian syndrome (PCOS) who are decided to be treated with ICSI. will be subjected to full history taking and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.

All patients will have standard pituitary down-regulation followed by follicle stimulating hormone (FSH) stimulation until the day of Human chorionic gonadotrophin (HCG) administration.

On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is defined as number of follicles measuring≥16mm. Follicular output rate (FORT) will be calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).

FORT correlation to pregnancy will be compared to that of the preovulatory count number

详细描述

Our study is observational, we are observing data from routine measurements during IVF/ICSI. Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI and preovulatory count which are calculated by observing routine measurements during the IVF/ICSI procedure.

All women fulfilling the inclusion criteria will be invited to participate in the study. A written informed consent will be taken and only women signing the consent will be included in the study. Patients included in the study will be subjected to full history taking and clinical examination including general, abdominal and gynecological examination. This will be followed by a vaginal ultrasound scan to assess uterus, ovaries and any pelvic masses.

All women will go through the usual IVF/ICSI procedure explained below, our aim is to observe the antral follicle count, the pre-ovulatory count, and calculate the FORT.

On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.

All patients will have standard pituitary down-regulation protocol with GnRHa (Triptorelin 0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of the oral contraceptive cycles. GnRHa will be continued for 2 weeks. FSH (Fostimon ®IBSA) 150-300 IU/day will be administered until the day of HCG administration.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCOS diagnosed using the Rotterdam criteria
  • Age 20-40 years
  • Both ovaries are present
  • Day 2 FSH <10 mIU/L
  • Day 2 Estradiol<50 pg/L

排除标准

  • Other causes of subfertility
  • Abnormalities affecting the uterine cavity
  • Uncontrolled diabetes
  • Allergy to gonadotrophins
  • Cancelled cycles during the study

结局指标

主要结局

clinical pregnancy

时间窗: 5 weeks after embryo transfer

FORT values will be classified into 3 categories: low, medium and high. The proportion of women achieving a clinical pregnancy will be compared among the 3 groups. Correlation of FORT with clinical pregnancy will be compared with the correlation of preovulatory count with pregnancy using a regression analysis. Clinical pregnancy will be defined as the presence of an intra-uterine gestational sac detected by ultrasound scanning.

次要结局

  • Number of embryos(3 days after embryo transfer)
  • Quality of embryos(3 days after ovum pick up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AbdelGany Hassan

Lecturer

Cairo University

研究点 (2)

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