Use of Autologous Exosomes vs Platelet Growth Factors to Regenerate the Ovary in Women With Infertility (Exosomas2024-1)

Summary

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.

Conditions

• Infertility, Female
• Reproductive Techniques, Assisted

Interventions

PROCEDURE

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 the exosomes were filtered using the EXOSMAT kit for autologous platelet exosomes. A total of 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.

PROCEDURE

Patient group for activated platelet growth factors

the plasma was placed in two 5 cc injectors to place 2 to 3 cc in each ovary (in the ovarian cortex) with the patient sedated. The PRP was placed transvaginally and using a follicular aspiration needle for the PRP group. All biostimulations were performed in early follicular phase (day 7, 8 or 9) in all groups according to their assigned technique.

PROCEDURE

the control group

Finally, the control group received 2 to 3 cc of physiological solution in each ovarian cortex for 4 cycles as the two previous groups. All these procedures were performed transvaginally under controlled surgical sedation with follicular aspiration needle in the ovarian cortex and guided by transvaginal echosonogram

Sponsors & Collaborators

• Biotech Fertility C.A.

  lead OTHER

Principal Investigators

• Carmen T Navarro Arrieta, Odontology · Biotech Fertility C.A.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

38 Years

Max Age

48 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-03

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Venezuela

Study Locations