The Evaluation of Infertility and Pregnancy Outcomes, as Well as the Assessment of Quality of Life Using WHOQoL and FertiQoL, in Cases of Gynecological Malignancies That Have Undergone Fertility-sparing Surgery(FSS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of pregnancy of patients received FSS
研究概览
简要总结
FSS which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. It is important to assess how FSS affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. This research aims to provide valuable insights into the long-term effects of FSS on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.
详细描述
This is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. Women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. Participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the WHOQoL-BREF and FertiQoL scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gynecologic cancer, and being fertile in the meantime
- •Applying directly to gynecologic oncology department
- •Demand of preserving the fertility
排除标准
- •Having hysterectomy prior to the diagnosis
- •Having bilateral ooferectomy prior to the diagnosis
- •Being in menopause
- •Not accepting to fill the survey
- •High stage disease which is not able to have FSS
结局指标
主要结局
Incidence of pregnancy of patients received FSS
时间窗: In 12 years after FSS
Incidence and rate of patients getting pregnant after FSS
Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics
时间窗: In 12 years after FSS
Rate of patients referring to IVF clinic after FSS
次要结局
- Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS(12 years)
研究者
Nazli Albayrak
PGY-4 Ob/Gyn resident, MD
Acibadem University