Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?

July 30, 2023 updated by: Laura Melado, ART Fertility Clinics LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
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: 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.
Control
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of new ovarian follicles (number of follicles growing) with evidence of estradiol production.
Time Frame: 12 weeks

Evaluate the difference of number of follicles growing, means values will be calculated at the two points time (baseline and 12 weeks).

Means differences will be verified using the t test analysis (after confirming the normal distribution of the data by means of Kolmogorov-Smirnoff tests. If normal distribution is not confirmed a non-parametric anova test will be used. This rule will be applied to all analysis
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in serum AMH above the baseline level
Time Frame: 12 weeks
Evaluate the difference of AMH levels between time, means values will be calculated at the two points time (baseline and 12 weeks). Means differences will be verified using the t test analysis.
12 weeks
Increase in AFC above the baseline level in 12 weeks
Time Frame: 12 weeks
Evaluate the difference of AFC levels between groups, means values will be calculated at the two points time (baseline and 12 weeks). Means differences will be verified using the t test analysis
12 weeks
Total number of retrieved oocytes in an IVF cycle.
Time Frame: 1 day
Number of retrieved oocytes will be calculated in the IVF cycle: total and per groups (per ovary)
1 day
Pregnancy rates
Time Frame: 40 weeks

Pregnancy rates:

  1. Biochemical pregnancy rate: Percentage of bHCG above 15 IU/ml per embryo transfer performed.
  2. Clinical pregnancy rate: percentage of pregnancies with fetal heart rate positive per embryo transfer performed. Miscarriage rate: percentage of miscarriages per embryo transfer
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Laura Melado, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2021

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-ABU-003-LM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on autologous platelet rich plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe