Efficacy of Autologous Exosomes vs Platelet-derived Growth Factors for Ovarian Regeneration in Women With Ovarian Insufficiency and Infertility: Observational, Prospective, Randomized, Comparative, Double-blind, Analytical, Prospective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Phase
研究概览
简要总结
Ovarian stromal fibrosis resulting from each ovulation and due to aging is characterized by a decrease in hyaluronic acid concentrations, loss of synthesis and migration proteins CD63 and CD81, decreased miRNA125, miRNA21, miRNA132 and miRNA199. Also, enzymatic alterations affecting kinases and mitochondrial sirtuins SIRT3-5 with increased oxygen free radicals preventing the normal maintenance and development of folliculogenesis, leading to the inability to reproduce at advanced ages and accelerating the onset of pathologies secondary to the decrease of ovarian estrogens. Methodology: An observational, prospective, randomized, comparative, double-blind, analytical pilot study in 30 women between 38 and 46 years of age, with diminished ovarian reserve and who refused the egg donation procedure. Three groups were designated: one for autologous exosomes, one for PRP and one with physiological solution.
详细描述
METHODOLOGY AND STUDY DEVELOPMENT
This study is an observational, prospective, randomized, comparative, double-blind, and analytical investigation conducted at a fertility clinic in Caracas, Venezuela, from January 2024 to September 2024. The study involved an ovarian biostimulation or bioregeneration procedure performed on 30 patients aged 38 to 46 years with low ovarian reserve who wished to conceive using their own eggs and declined egg donation.
Patient selection criteria were based on parameters indicative of decreased ovarian reserve at the study's onset. These included hormonal levels measured on the third day of each patient's menstrual cycle: Follicle-Stimulating Hormone (FSH) greater than 12 mIU/mL, Estradiol less than 35 pg/mL, and Anti-Müllerian Hormone (AMH) less than 0.7 ng/mL. Additionally, patients had to present a total antral follicle count of fewer than five follicles across both ovaries, confirming low ovarian reserve or ovarian resistance, alongside a documented refusal to use donor eggs.
An intraovarian injection protocol was implemented based on three different treatment groups:
Autologous Exosomes obtained from the patient's platelets, Activated Platelet Growth Factors and Physiological Solution (control group).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 38 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients between 38 and 46 years of age.
- •Patients with a desire to become a mother
- •Patients with Body Mass Index (BMI) between 23 and
- •Patients with proven ovarian insufficiency, according to the parameters mentioned above.
- •Patients who refuse egg donation.
- •Patients with full willingness to participate in the study and who have understood and signed the informed consent.
- •Patients with both ovaries without oncological pathologies, active endometriomas or suspicious ovarian or other tumors.
- •Patients with platelet count over 250 thousand.
- •Patients with no history of hematological diseases.
- •Patients without treatment with anticoagulants.
- •Patients with no active infection at the time.
排除标准
- •Female patients outside the age range of 38 to 46 years old.
- •Patients who are not willing to become mothers.
- •Patients with a BMI outside the range of 23 to 30
- •Patients without ovarian insufficiency
- •Patients who do not wish to participate in the procedure and have not signed the informed consent form.
- •Patients with suspected or diagnosed oncological diseases.
- •Patients with platelet count of less than 250 thousand
- •Patients with a history of hematological diseases.
- •Patients with anticoagulant treatment.
- •Patients with any type of active infection.
研究组 & 干预措施
Autologous Exososomes procedure obtained from the patients' own platelets.
Intraovarian injection (into the ovarian cortex) was performed over four cycles, once a month in each ovary on days 7, 8, or 9 of the menstrual cycle. Blood was drawn using the selected PRP kit; in this case, all the PRP was placed into two 20 cc syringes and filtered for exosomes using the EXOSMAT kit for autologous platelet exosomes. As a result, 5 to 6 cc of liquid composed exclusively of platelet-derived exosomes was obtained, with a concentration of 5 to 6 trillion exosomes per milliliter. Finally, 2 to 3 cc were administered to each ovary via the transvaginal route.
干预措施: Autologous Exososomes procedure obtained from the patients' own platelets. (Procedure)
Patient group for activated platelet growth factors
Intraovarian injection (into the ovarian cortex) was performed over four cycles, once a month in each ovary on days 7, 8, or 9 of the menstrual cycle. The plasma was prepared in two 5 cc syringes to administer 2 to 3 cc into each ovary (into the ovarian cortex) with the patient under sedation. The PRP was applied via the transvaginal route using a follicular aspiration needle for the PRP group.
干预措施: Patient group for activated platelet growth factors (Procedure)
3. Group of patients for physiological solution.
A total of 2 to 3 cc of saline solution was administered into each ovarian cortex over four cycles, following the same protocol as the previous two groups.
干预措施: the control group (Procedure)
结局指标
主要结局
Primary Phase
时间窗: Follow-up for 12 weeks for each patient.
This study was carried out on a total of 30 patients, with an average age of 41.20 ± 2.86 years, for a minimum age of 38 and a maximum of 46 years (53.3% with ages ≤ 40 years and 46.7% aged \> 40 years), with a desire to become mothers, with a previous diagnosis of resistance or ovarian failure and who also refuse egg donation.
次要结局
- Follow-ups at birth(From the procedure to birth)
研究者
Carmen Navarro
Human Reproduction Specialist
Biotech Fertility C.A.