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Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?

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ClinicalTrials.gov Identifier: NCT04381299
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Laura Melado, ART Fertility Clinics LLC

Tracking Information
First Submitted Date May 7, 2020
First Posted Date May 8, 2020
Last Update Posted Date July 29, 2020
Estimated Study Start Date November 1, 2020
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2020)
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
Original Primary Outcome Measures
 (submitted: May 7, 2020)
The main objective is the emergence of new ovarian follicles (number of follicles growing) with evidence of estradiol production. [ Time Frame: 12 weeks ]
To 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
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2020)
  • 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.
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures
 (submitted: May 7, 2020)
  • Increase in serum AMH above the baseline level [ Time Frame: 12 weeks ]
    To 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.
  • Increase in AFC above the baseline level in 12 weeks [ Time Frame: 12 weeks ]
    To 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
  • Retrieval of 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)
  • IVF outcomes [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?
Official Title Is Autologous Platelet Rich Plasma Able To Restore Ovarian Function? A Prospective Randomized Control Trial.
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, 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample
Sampling Method Probability Sample
Study Population Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment.
Condition
  • Infertility
  • IVF
  • Premature Ovarian Failure
  • Anti-Mullerian Hormone Deficiency
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: autologous platelet rich plasma
  • 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.
    Intervention: Other: saline solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 7, 2020)
35
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Barbara Lawrenz, PhD +97126528000 ext 1108 barbara.lawrenz@ivirma.com
Contact: Shieryl Digma, RN +97126528000 ext 1122 shieryl.digma@ivirma.com
Listed Location Countries United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT04381299
Other Study ID Numbers 2004-ABU-003-LM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Laura Melado, ART Fertility Clinics LLC
Study Sponsor ART Fertility Clinics LLC
Collaborators Not Provided
Investigators
Principal Investigator: Laura Melado, PhD IVI Middle East Fertility Clinic LLC
PRS Account ART Fertility Clinics LLC
Verification Date July 2020