NCT04381299

Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?

Is Autologous Platelet Rich Plasma Able To Restore Ovarian Function? A Prospective Randomized Control Trial.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: ART Fertility Clinics LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A-PRP (Autologous Platelet Rich Plasma) is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This study will involve adult women with a diagnosis of Premature ovarian insufficiency (POI) willing to perform an IVF/ICSI treatment.

Detailed description

POI is a loss of normal function before age 40, leading to infertility and hypergonadotropic hypoestrogenism. Currently, no optimal regimen exists to ameliorate ovarian function. The options to conceive genetically related offspring, are limited. Typically, affected patients end up with egg donation or adoption as an alternative . A-PRP is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product and is widely used via injection into various organs and tissues, safety concerns are minimal. This study will involve adult women with a diagnosis of Premature ovarian insufficiency (POI) willing to perform an IVF/ICSI treatment. A-PRP will be prepared using Eclipse PRP Kit which is approved by US FDA for preparation of PRP. Consenting participants will receive injections of autologous Platelet Rich Plasma (A-PRP) in one randomly selected ovary under ultrasound guidance performed under IV sedation. As it is suggested that only mechanical stimulation by biopsy/scratch could be a potentially effective method for follicle activation, the other ovary will be injected with the same amount of Saline Solution (SS) as control, to replicate the same mechanical effect. Randomization will determine whether the right or left ovary will be treated. Follow up of the participants will be performed with transvaginal ultrasound and hormonal tests including AMH, FSH, LH, estradiol and progesterone, every 10 days for the next 3 months after the injection. If ovarian activity is detected, the participant will undergo an IVF treatment.

Conditions

• Infertility
• IVF
• Premature Ovarian Failure
• Anti-Mullerian Hormone Deficiency

Interventions

Type	Name	Description
OTHER	autologous platelet rich plasma	The cortex of selected ovary will be injected with 1 mL of autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.
OTHER	saline solution	The cortex of contralateral ovary will be injected with 1 mL of saline solution (SS). Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.

Timeline

• Start date: 2021-04-25
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-05-08
• Last updated: 2025-02-19

Locations

1 site across 1 country: United Arab Emirates