Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve
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
- 1
- 主要终点
- Number of oocytes recovered
研究概览
简要总结
The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve.
Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion.
Secondary Objectives
- To compare pre- and post-treatment pregnancy rates.
- To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1
- Patient Selection
- Confirm that he/she has all the analyses and variables to be studied.
- Signing of Informed Consent
- Usual IVF protocol (1st IVF cycle) VISIT 2
- Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3
- Analytical control at 4 weeks VISIT 4
- Analytical control at 8 weeks VISIT 5
- In case of failure to achieve gestation Start of 2nd cycle of IVF
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of childbearing age as defined by the CTFG*.
- •Women in group 3 and 4 of the POSEIDON classification for low reserve:
- •POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- •POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- •Patients with at least one ovary.
- •Infertility of more than 1 year duration.
- •Provision of safe ovarian access on the day of the puncture.
- •They agree to participate and to give their written consent.
排除标准
- •Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
- •Patients with ongoing pregnancy
- •Current or previous IgA deficiency,
- •Ovarian failure secondary to identified genetic causes.
- •Presence of pelvic adhesions after abdominal surgery.
- •Chronic use of aspirin, NSAIDs or anticoagulants.
- •Diseases that alter platelet number or function.
- •Psychiatric disorder that precludes participation in the study (including active substance abuse or dependence).
- •Obesity (BMI ≥ 30).
- •Current female smokers (≥ 15 cigarettes per day) - Current smoking (≥ 15 cigarettes per day)
- •Patients affected by neoplastic disease
- •Severe male factor infertility
研究组 & 干预措施
Patients starting ovarian stimulation cycle for FIV-ICSI cycle
干预措施: Plasma Rich in Growth Factors (PRGF) (Biological)
结局指标
主要结局
Number of oocytes recovered
时间窗: visit 4 weeks and visit 8 weeks
Number of MII (metaphase II stage oocyte) on the day of the puncture
时间窗: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
Number of fertilised oocytes
时间窗: visit 4 weeks and visit 8 weeks
Number of embryos obtained per EOC (ovarian stimulation) cycle
时间窗: visit 4 weeks and visit 8 weeks
Number of embryos of good quality (A or B quality according to ASEBIR classification).
时间窗: visit 4 weeks and visit 8 weeks
Number of frozen embryos
时间窗: visit 4 weeks and visit 8 weeks
Number of cycles cancelled pre-puncture
时间窗: Day 1
Ovarian reserve markers
时间窗: Day 1 vs visit 4 weeks
Number of cycles cancelled post-puncture
时间窗: visit 4 weeks and visit 8 weeks
次要结局
未报告次要终点