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临床试验/NCT03345030
NCT03345030Unknown不适用

The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome

Suleyman Demirel University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Clinical pregnancy defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer

研究概览

简要总结

Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by comet assay in unexplained infertile patients undergoing in vitro fertilization (IVF) treatment. The oocytes will be graded by particular criteria. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy, pregnancy outcomes (gestational age at delivery, route of delivery, and birthweight etc.) will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between unexplained infertile and control groups. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

详细描述

Granulosa cells surrounding the oocytes will be mechanically obtained during the oocyte pick-up procedure in women undergoing in vitro fertilization (IVF) treatment due to unexplained infertility. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by comet assay. The quality of oocytes retrieved during the oocyte pick-up procedure will be graded by particular criteria (zona pellucida thickness, granulation, vacuolization, etc). Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates, and pregnancy outcomes including gestational age at delivery, route of delivery, and birthweight will be recorded as well as demographic data such as age, body-mass index, smoking, alcohol use, employment, coexisting chronic disease, infertility duration, etiology of infertility, treatment protocol, and hormone levels on day 3. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 12 following an embryo transfer. Clinical pregnancy will be diagnosed upon presence of gestational sac on ultrasound examination. DNA damage of granulosa cells will be compared between unexplained infertile group and control group. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

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
19 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Unexplained infertile patients undergoing in vitro fertilization (IVF) treatment

排除标准

  • Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
  • Endocrinopathy (Thyroid, prolactin... abnormalities)
  • Chemotherapy or radiotherapy history
  • Cigarette, alcohol, chronic medication use
  • Diminished ovarian reserve
  • Endometriosis
  • Having any medication use
  • History of any surgical procedure on ovaries and uterus
  • Smoking or alcohol consumption
  • Severe oligoasthenospermia
  • Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease

结局指标

主要结局

Clinical pregnancy defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer

时间窗: 5 weeks after embryo transfer

Presence of a gestational sac in transvaginal ultrasonographic examination

次要结局

  • Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure(1 day after intracytoplasmic sperm injection procedure)
  • Oocyte grade assessed by four parameters (cytoplasmic granulation, properties of the polar body, the perivitelline space and properties of the zona pellucida) under invert microscope 36 hours after human chorionic gonadotropin administration(36 hours after human chorionic gonadotropin administration)
  • Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure(3 days after intracytoplasmic sperm injection procedure)
  • Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer(12 days after embryo transfer)

研究者

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

Esra Nur tola

Assisstant Professor Doctor

Suleyman Demirel University

研究点 (2)

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