Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Positive IVF
研究概览
简要总结
The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat infertility in women experiencing menopause, perimenopause, and premature ovarian failure.
详细描述
This research extends earlier work conducted by Inovium associates in Athens, Greece who demonstrated efficacy of intraovarian injection of autologous PRP for resumption of menses, hormone stabilization, and conception after IVF in multiple women following PRP+natural cycle IVF (i.e., without gonadotropin stimulation). The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring during this clinical trial aims to characterize more fully the transition from PRP dosing, embryogenesis, IVF and conception.
The current study seeks to describe how PRP works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful IVF sequences and conceptions. The quality of all embryos generated will be studied via PGS, with the goal of generating euploid embryos. Hormone stability and biomarkers of aging will also be evaluated to understand the extent of any observed benefits, and to estimate how long such effects may be sustained with a single PRP treatment.
Autologous activated PRP used in this clinical study is isolated from patient derived (blood) samples collected on-site, using FDA-approved Regenlab [Lausanne, Switzerland] BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval #BK110061; ISO#13485).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent
- •Women over the age of 35
- •Primary or secondary amenorrhea at least for 3-6 months
- •Presence of at least one ovary
- •Agree to report any pregnancy to the research staff immediately.
- •Willing and able to comply with study requirements.
- •Willing to receive IVF to get pregnant as part of the experimental protocol.
排除标准
- •Men will be excluded from the study.
- •Current or previous IgA deficiency
- •Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
- •Current or previous great injuries or adhesions to the pelvis or ovaries
- •Current and ongoing pregnancy
- •Current and ongoing anticoagulant use for which plasma infusion appears contraindicated
- •Current and ongoing major Mental health disorder that precludes participation in the study
- •Current and ongoing active substance abuse or dependence
- •Current and ongoing gynecological or non-gynecological cancer
- •Current and ongoing chronic pelvic pain
结局指标
主要结局
Positive IVF
时间窗: 12 months
Following the initial Ovarian Rejuvenation Treatment, subjects will undergo IVF treatment to test the efficacy of the Protocol for fertility outcomes, as per trial protocols.
Positive Pregnancy and Conception
时间窗: 12 months
Following completion of trial protocols, patients will conduct ongoing post-treatment follow-up with trial staff for recording progress of all ongoing pregnancies and conceptions, via post-treatment correspondence.
次要结局
- Resumption of Menses(12 months)
- Duration of Identified Benefits of Treatment(12 months)
- Changes in Health Outcomes(12 months)
- Changes in Menopausal Symptoms(12 months)
- Changes in Egg Quality(12 months)
- Changes in Hormone Levels(12 months)