DONOVO-Nancy: Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital: an Overview of the Donor Journey Since the Revisions to the Bioethics Laws
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of donor candidates undergoing oocyte retrieval
研究概览
简要总结
Since the 2021 revision of French bioethics laws, access to assisted reproductive technologies (ART) has expanded, leading to a significant increase in gamete donation requests. In this context, oocyte donation remains a limited resource, with marked disparities between centers and persistent donor shortages.
At the Assisted Reproductive Technology Center of Nancy University Hospital, more than fifty women have initiated an oocyte donation process since the implementation of the new legislation. However, not all candidates complete the donation pathway, and clinical and organizational outcomes have not yet been formally evaluated.
This retrospective observational study will evaluate the oocyte donation pathway at the Assisted Reproductive Technology Center of Nancy University Hospital. The study population will include all women who attended a biological consultation for primary or secondary oocyte donation from the implementation of the new Bioethics laws until December 31, 2025 (study period).
Baseline clinical and biological characteristics of donor candidates will be described, including age, body mass index, anti-Müllerian hormone level, and antral follicle count.
The proportion of donor candidates undergoing oocyte retrieval and the time interval between the first biological consultation and oocyte retrieval will be assessed.
Biological and clinical outcomes will also be analyzed, including the number of oocytes retrieved, the number of mature oocytes (metaphase II) obtained, fertilization rate following in vitro fertilization, clinical pregnancy rate per embryo transfer, and live birth rate.
Results will be compared with national data reported by the French Biomedicine Agency in order to evaluate the activity and outcomes of the center and to identify potential areas for organizational and clinical improvement in the oocyte donation pathway.
The overall objective is to optimize donor management and improve access to oocyte donation for recipient patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women who attended a biological consultation for primary or secondary oocyte donation at Nancy University Hospital during the study period.
排除标准
- •Absence of biological consultation for oocyte donation during the study period ;
- •Insufficient or missing medical data ;
- •Documented opposition to data use for research purposes.
研究组 & 干预措施
Candidates for egg donation
结局指标
主要结局
Proportion of donor candidates undergoing oocyte retrieval
时间窗: From the first biological consultation until oocyte retrieval, assessed up to 12 months
Proportion of patients who underwent oocyte retrieval following ovarian stimulation among all donor candidates who attended a biological consultation for oocyte donation at Nancy University Hospital during the study period. The outcome will be reported as a percentage (number of oocyte retrieval procedures divided by the total number of donor candidates evaluated).
次要结局
- Mean number of oocytes retrieved per oocyte retrieval procedure(At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation)
- Mean time from first biological consultation to oocyte retrieval(From the first biological consultation until oocyte retrieval, assessed up to 12 months)
- Median number of mature oocytes (metaphase II) retrieved per donor(At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation)
- Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection(1 day after fertilization)
- Clinical pregnancy rate per embryo transfer(From embryo transfer until confirmation of clinical pregnancy by ultrasound, assessed up to 8 weeks after embryo transfer)
- Live birth rate following oocyte donation cycles(From embryo transfer until delivery, assessed up to 41 weeks of gestation)
研究者
AIMONE VIANNA Caroline
Doctor in Medicine - Hospital physician
Central Hospital, Nancy, France