Status:

ACTIVE_NOT_RECRUITING

Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?

Lead Sponsor:

ART Fertility Clinics LLC

Conditions:

Infertility

IVF

Eligibility:

FEMALE

18-40 years

Brief 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, wo...

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 concei...

Eligibility Criteria

Inclusion

  • Signed and dated informed consent
  • Women 40 years of age and younger with documented primary ovarian insufficiency (12).
  • Normal Karyotype
  • BMI \</= 35 kg/m2
  • Oligo/amenorrhea for at least 4 months
  • FSH \> 25 IU/mL
  • AMH \</= 0,1 ng/ml
  • No evidence of follicles \> 4mm
  • Must have two ovaries of approximately equal volume.
  • Willingness to undergo further fertility treatment, including IVF if there is evidence of response
  • A transvaginal scan including Doppler for arteria ovarica will be performed previously to the surgical procedure.

Exclusion

  • Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality.
  • Oncological diseases (specially, skeletal system and blood).
  • Autoimmune diseases, for example, lupus erythematosus, etc.
  • Previous treatments including radiotherapy or chemotherapy.
  • Other conditions not suitable for surgical procedures and/or anesthesia.
  • Anticoagulant or antiaggregant treatment.
  • Acute and chronic infectious diseases.
  • Active substance abuse or dependence.
  • Major Mental health disorder.

Key Trial Info

Start Date :

April 25 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT04381299

Start Date

April 25 2021

End Date

December 31 2025

Last Update

February 19 2025

Active Locations (1)

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ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202