Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection Outcome in Women With Unexplained Infertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Clinical pregnancy
研究概览
简要总结
300 women with unexplained infertility who are already decided to be treated with ICSI will be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.
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 (Human menopausal gonadotrophin (HMG) 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. FORT will be calculated as: (PFC) * 100/AFC.
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 FORT which is calculated by observing routine measurements during the IVF/ICSI procedure.
300 women with unexplained infertility who are already decided to be treated with ICSI will be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.
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 then correlating this with pregnancy.
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.
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
- 否
入选标准
- •Unexplained infertility
- •Both ovaries are present
- •Day 2 FSH <10 mIU/L
- •Day 2 Estradiol <80 pg/L
排除标准
- •Known other cause of subfertility
- •Expected poor responders according to Bologna criteria (9)
- •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. Clinical pregnancy will be defined as the presence of an intra-uterine gestational sac detected by ultrasound scanning.
次要结局
- Retrieved oocytes(1 hour after ovum pick up)
- Number of embryos(3 days after ovum pick up)
- Quality of embryos(3 days after ovum pick up)