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Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women (PRP)

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ClinicalTrials.gov Identifier: NCT03951194
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Genesis Athens Clinic

Brief Summary:
Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

Condition or disease Intervention/treatment Phase
Infertility, Female Perimenopausal Disorder Menstrual Cycle Abnormal Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion Phase 2 Phase 3

Detailed Description:
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on improving ovarian tissue functionality in perimenopausal women.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Arm Intervention/treatment
Experimental: Participants receiving PRP treatment
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
Autologous PRP intra ovarian infusion
Other Names:
  • PRP
  • Platelet Rich Plasma

Placebo Comparator: Participants receiving Platelet Free Plasma (PFP)
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Autologous PFP intra ovarian infusion
Other Names:
  • PFP
  • Platelet Free Plasma




Primary Outcome Measures :
  1. Restoration of menstrual cycle regularity [ Time Frame: Three months ]
    Regular Menstrual cycle

  2. Serum FSH levels [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    Serum FSH levels evaluated monthly for three consecutive months.


Secondary Outcome Measures :
  1. Serum AMH levels [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    Serum AMH levels evaluated monthly for three consecutive months.

  2. Serum LH levels [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    Serum LH levels evaluated monthly for three consecutive months.

  3. Serum Estradiol levels [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    Serum etsradiol levels evaluated monthly for three consecutive months.

  4. Serum Progesteron levels [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    Serum progesterone levels evaluated monthly for three consecutive months.

  5. Antral Follicle Count [ Time Frame: Follow-up period of three months entailing monthly evaluation ]
    AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months.



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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.
  • Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
  • Willing to comply with study requirements

Exclusion Criteria:

  • Any pathological disorder related to reproductive system anatomy
  • Amenorrhea
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of cancer in reproductive system
  • History of familiar cancer in reproductive system
  • Severe male factor infertility
  • Prior referral for PGT
  • Ovarian inaccessibility
  • Previous POI diagnosis -Endocrinological disorders (Hypothalamus-
  • Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
  • BMI>30 kg/m2 or BMI<18.5 kg/m2
  • Systematic autoimmune disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951194


Contacts
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Contact: Mara Simopoulou, PhD +306979234100 marasimopoulou@hotmail.com
Contact: Agni Pantou, MD, PhD Candidate agni.pantou@genesisathens.gr

Locations
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Greece
Genesis AC Recruiting
Athens, Greece, 15232
Contact: Agni Pantou, MD, PhD Candidate       agni.pantou@genesisathens.gr   
Contact: Konstantinos Pantos, MD,PhD         
Sponsors and Collaborators
Genesis Athens Clinic
National and Kapodistrian University of Athens
Investigators
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Study Director: Agni Pantou, MD Obstetrician Gynecologist
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Responsible Party: Genesis Athens Clinic
ClinicalTrials.gov Identifier: NCT03951194    
Other Study ID Numbers: PRP- Perimenopause
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female