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临床试验/NCT01223118
NCT01223118已完成不适用

Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes

Reproductive Medicine Associates of New Jersey4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
4
主要终点
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)

研究概览

简要总结

The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

详细描述

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.

There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No prior failed IVF treatment cycle
  • Female partner less than 35 years of age at time of onset of the IVF cycle
  • Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
  • Total basal antral follicle count greater than or equal to 12
  • Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
  • Body Mass Index (BMI) ≤ 32 kg/m2

排除标准

  • Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
  • Diagnosis of endometrial insufficiency
  • Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
  • Use of testicular aspiration or biopsy procedures to obtain sperm
  • Unevaluated ovarian mass
  • Presence of hydrosalpinges which communicate with the endometrial cavity
  • Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation

结局指标

主要结局

Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)

时间窗: 1 year

Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.

次要结局

  • Delivery rates(1 year)
  • Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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