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Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women (PRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916978
Recruitment Status : Recruiting
First Posted : April 16, 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 restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

Condition or disease Intervention/treatment Phase
Infertility, Female Anovulatory Infertility Menopause Amenorrhea Biological: Autologous PRP intra ovarian infusion Biological: Autologous 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 reactivating ovarian functionality and on promoting folliculogenesis in regard to menopausal 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 restoring ovarian tissue functionality in menopausal 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 Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Participants receiving PRP treatment
Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.
Biological: Autologous PRP intra ovarian infusion
Autologous PRP intra ovarian infusion

Placebo Comparator: Control Group: Participants receiving Platelet Free Plasma
Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.
Biological: Autologous PFP intra ovarian infusion
Autologous PFP intra ovarian infusion




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

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

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

  4. Serum progesterone 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 45-55 years old
  • Amenorrhea for at least 12 months
  • 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
  • Previous POI diagnosis
  • Abnormal karyotype
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of reproductive system cancer
  • History of familiar cancer in reproductive system
  • Severe male factor infertility
  • Prior referral for PGT
  • Ovarian inaccessibility
  • 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): NCT03916978


Contacts
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Contact: Mara Simopoulou, PhD +306979234100 marasimopoulou@hotmail.com
Contact: Agni Pantou, MD +306974447702 agni.pantou@genesisathens.gr

Locations
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Greece
Genesis AC Recruiting
Athens, Greece, 15232
Contact: Agni Pantou, MD       agni.pantou@genesisathens.gr   
Principal Investigator: Agni Pantou, MD         
Principal Investigator: Konstantinos Pantos, MD,PhD         
Sponsors and Collaborators
Genesis Athens Clinic
National and Kapodistrian University of Athens
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Responsible Party: Genesis Athens Clinic
ClinicalTrials.gov Identifier: NCT03916978    
Other Study ID Numbers: PRP - Menopausal women
First Posted: April 16, 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
Keywords provided by Genesis Athens Clinic:
Ovarian rejuvenation
Ovarian reactivation; ovulation
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Amenorrhea
Menstruation Disturbances
Pathologic Processes