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Evaluation of the Impact of Vitrification on Oocytes

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

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.

研究概览

地位

完全的

条件

详细说明

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).

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • Morristown、New Jersey、美国、07960
        • Reproductive Medicine Associates of New Jersey
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18104
        • Reproductive Medicine Assoicates of PA at Lehigh Valley

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

Inclusion Criteria:

  1. No prior failed IVF treatment cycle
  2. Female partner less than 35 years of age at time of onset of the IVF cycle
  3. Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
  4. Total basal antral follicle count greater than or equal to 12
  5. 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
  6. Body Mass Index (BMI) ≤ 32 kg/m2

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Oocyte Vitrification
Each patient will have oocytes randomized into two groups immediately after retrieval. Half of oocytes will be vitrified, thawed and inseminated. The other half will be inseminated only. All embryos will be biopsied for PGD prior to transfer and one embryo from each group will be transferred (vitrification and control groups). Following delivery, buccal swabs will be collected on all infants.
Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.
其他名称:
  • PGD
  • Vitrification

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)
大体时间:1 year
Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
1 year

次要结果测量

结果测量
措施说明
大体时间
Delivery rates
大体时间:1 year
All embryos will be biopsied prior to transfer and DNA samples will be collected from all infants. Compare embryonic and infant DNA to evaluate whether the live birth resulted from a vitrified or a fresh/control oocyte.
1 year
Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)
大体时间:1 year
Among patients with a paired two blastocyst transfer, compare the implantation rate of embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Richard T Scott, MD、Reproductive Medicine Associates of New Jersey

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2012年7月1日

研究注册日期

首次提交

2010年10月8日

首先提交符合 QC 标准的

2010年10月15日

首次发布 (估计)

2010年10月18日

研究记录更新

最后更新发布 (估计)

2013年1月23日

上次提交的符合 QC 标准的更新

2013年1月22日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • RMA-2010-02

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Vitrification and PGD的临床试验

3
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