跳至主要内容
临床试验/CTRI/2023/02/049685
CTRI/2023/02/049685招募中2/3 期

Ovarian tissue cryopreservation (OTC) for fertility preservation in young cancer survivors- Comparison of slow freezing and vitrification techniques

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月15日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
20
试验地点
1
主要终点
Comparing the two methods of cryopreservation we shall assess the survival of cryo-

研究概览

简要总结

Recent advancements have improved survival of cancer patients. Treatment is gonadotoxic resulting in loss of reproductive functions. Oncofertility involves managing cancer survivors with options of fertility preservation (FP) prior to chemo/radiotherapy. Options in females include stimulating ovaries and harvesting oocytes or creating embryos and freezing them in unmarried and married females respectively. This requires a hiatus of 2-3 weeks pre therapy. Oocyte and embryo cryopreservation are established methods of FP for adults. However, for pubertal and young girls who do not have sufficient mature oocytes ovarian tissue cryopreservation (OTC) and auto-transplantation is the only option.  OTC is still considered experimental, perhaps setting and standardization of techniques are challenging. The standard process of OTC has been slow freezing programmed with defined cryoprotectants. The other technique is vitrification which is associated with less cellular damage with no intra-cellular ice crystal formation. Though favoured for gametes and embryos, vitrification is still not widely accepted for OTC and studies comparing both techniques suggest conflicting results.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • i)Patients with good prognosis for survival after chemo/radiotherapy requiring OTC a.Pubertal ages with malignancy b.Adults in reproductive years for immediate chemo/radiotherapy with little time for oocyte/embryo freezing as this requires 2-3 weeks of ovarian stimulation and oocyte recovery and embryo culture ii)Willing to participate in the study.

排除标准

  • i)Patients with poor prognosis for survival ii)Medical complications not permitting laparoscopy/anaesthesia to harvest ovarian tissue iii)Not willing to participate in study.

结局指标

主要结局

Comparing the two methods of cryopreservation we shall assess the survival of cryo-

时间窗: All tissue samples will be assessed at baseline(control) and post thawing (6 months)

preserved ovarian tissue by assessing:

时间窗: All tissue samples will be assessed at baseline(control) and post thawing (6 months)

ï‚· Primordial follicle count

时间窗: All tissue samples will be assessed at baseline(control) and post thawing (6 months)

ï‚· Proportion of viable primordial follicle

时间窗: All tissue samples will be assessed at baseline(control) and post thawing (6 months)

ï‚· Extent of DNA damage to primordial follicles

时间窗: All tissue samples will be assessed at baseline(control) and post thawing (6 months)

次要结局

  • i)Proportion of intact or viable primordial follicles,(ii)Primordial follicle density and DNA fragmentation in primordial follicles.)

研究者

申办方类型
Government funding agency

研究点 (1)

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