PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial: A Randomized Controlled Trial of Gonadotropin Releasing Hormone Agonist (GnRHa) for Fertility Preservation in Oncology Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Protection against ovarian failure
研究概览
简要总结
The purpose of this study is to determine whether gonadotropin releasing hormone agonists (medical therapy) will protect against ovarian failure in reproductive aged women undergoing sterilizing chemotherapy.
详细描述
Fertility preservation is defined as the maintenance of one's ability to reproduce.
The hypothesis for this study is that medical treatment (GnRHa) will help female cancer patients, receiving sterilizing chemotherapy, preserve their ovarian function and therefore fertility. This study is a feasibility trial of the drug (GnRHa)vs placebo in female cancer patients receiving gonadotoxic chemotherapy between the ages of 18 and 38 who wish to participate.
The objective of the feasibility trial is to determine the feasibility of a definitive study to answer this question and also to define the required parameters needed to design the definitive study such as the observable difference in ovarian failure between the drug and placebo groups. The same protocol will be followed as proposed for the definitive trial but with a smaller sample size.
This pilot study will be conducted at the Ottawa Hospital Regional Cancer Centre/Division of Reproductive Medicine of Department of Obstetrics and Gynecology, University of Ottawa and the Cancer Centre of Southeastern Ontario/Division of Reproductive Medicine of Department of Obstetrics and Gynecology, University of Ottawa.
The planned trial intervention is trimonthly (every 3 months) administration of depot GnRHa (Leuprolide acetate (LA) 11.25 mg intramuscularly) or placebo. Injections would start prior to initiation of chemotherapy, in the luteal phase of the menstrual cycle preceding chemotherapy, and will continue until cessation of chemotherapy (maximum of 6 months or 2 injections). Since only adjuvant/curative chemotherapy patients will be enrolled, chemotherapy will last a maximum of six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Women who are:
- •between ages 18 to 38;
- •who will be undergoing gonadotoxic (sterilizing) curative/ adjuvant chemotherapy for early stage disease; and
- •have provided informed consent. All subjects will be enrolled from the Ottawa Hospital Regional Cancer Institute (OHRCC) and the Cancer Center of South Eastern Ontario at Kingston General Hospital (CCSEO).
排除标准
- •Women who:
- •have advanced stage disease and/or whose median survival is expected to be less than 6 months
- •have cancer of the ovaries, uterus, or fallopian tubes;
- •have clinical or biochemical evidence of diminished ovarian reserve (recent shortening of cycles < 24 days between menses, age > 38, elevated serum FSH (follicular stimulating hormone)> 15 IU/L, or low antral follicle count (AFC- number of follicles less than 10 mm on day 2 or 3 of natural menses) on baseline pelvic ultrasound (<5) or elevated day 2 or 3 estradiol (> 280 pmol/ml);
- •have previously received chemotherapy or abdominal/pelvic radiation or have planned to receive abdomino/pelvic radiation;
- •are pregnant;
- •have contraindications to intramuscular injections; or
- •have a history of fractures secondary to/or documented osteoporosis.
研究组 & 干预措施
Placebo
Placebo
干预措施: Leuprolide acetate (Drug)
depot GnRHa (Leuprolide acetate (LA) 11.25 mg intramuscularly)
干预措施: Leuprolide acetate (Drug)
结局指标
主要结局
Protection against ovarian failure
时间窗: 12 months post Chemo therapy
次要结局
- Sonographic (biophysical) and biochemical markers of ovarian reserve(3,6,9,12 months)