跳至主要内容
临床试验/NCT02396095
NCT02396095终止不适用

Live Birthrate Following Oocyte Cryopreservation

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
1
主要终点
Live birthrate following transfer of embryos created from frozen eggs

研究概览

简要总结

Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs.

详细描述

Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.

Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.

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
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 15 and 45
  • desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
  • willingness to participate in study and provide informed consent

排除标准

  • day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
  • ovarian cyst greater than 14mm at baseline ultrasound
  • uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
  • current pregnancy

结局指标

主要结局

Live birthrate following transfer of embryos created from frozen eggs

时间窗: 10 years

Live birthrate following transfer of embryos created from frozen eggs in the setting of: Autologous oocyte cryopreservation in women without cancer vs.autologous oocyte cryopreservation in women with cancer.

次要结局

  • Oocyte survival rates(10 years)

研究者

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

Clarisa Gracia

Clarisa R. Gracia, MD, MSCE

University of Pennsylvania

研究点 (1)

Loading locations...

相似试验