Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-22 @ 2:52 PM
Study NCT ID:
NCT04031456
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2017-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008594', 'term': 'Menopause, Premature'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restoration of menstrual cycle', 'timeFrame': 'Three months', 'description': 'Regular menstrual cycle'}, {'measure': 'Serum FSH levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum FSH levels evaluated monthly for three consecutive months'}], 'secondaryOutcomes': [{'measure': 'Serum AMH levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum ΑΜΗ levels evaluated monthly for three consecutive months'}, {'measure': 'Serum LH levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum LH levels evaluated monthly for three consecutive months'}, {'measure': 'Serum Estradiol levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum estradiol levels evaluated monthly for three consecutive months'}, {'measure': 'Serum Progesteron levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum progesterone levels evaluated monthly for three consecutive months'}, {'measure': 'Antral Follicle Count (AFC)', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause, Premature', 'Menopause Related Conditions', 'Menopausal Syndrome', 'Premature Ovarian Failure', 'Ovarian Failure, Premature']}, 'descriptionModule': {'briefSummary': "Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.", 'detailedDescription': "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 patients presenting with POI. 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 POI patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \\>25 IU/L recorded on two occasions \\>4 weeks apart\n* Normal Karyotype: 46, XX\n* Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.\n* Willing to comply with study requirements\n\nExclusion Criteria:\n\n* Any pathological disorder related to reproductive system anatomy\n* AMH \\> 8 pmol/L\n* Endometriosis\n* Adenomyosis\n* Fibroids and adhesions\n* Infections in reproductive system\n* Current or previous diagnosis of cancer in reproductive system\n* History of familiar cancer in reproductive system\n* Severe male factor infertility\n* Prior referral for PGT\n* Ovarian inaccessibility\n* Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)\n* BMI\\>30 kg/m2 or BMI\\<18.5 kg/m2\n* Systematic autoimmune disorders'}, 'identificationModule': {'nctId': 'NCT04031456', 'acronym': 'PRP', 'briefTitle': 'Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Genesis Athens Clinic'}, 'officialTitle': 'Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients', 'orgStudyIdInfo': {'id': 'PRP- POI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants receiving PRP treatment', 'description': 'Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion', 'interventionNames': ['Biological: Autologous Platelet Rich Plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Participants receiving Platelet Free Plasma (PFP) treatment', 'description': 'Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion', 'interventionNames': ['Biological: Placebo-Platelet Free Plasma']}], 'interventions': [{'name': 'Autologous Platelet Rich Plasma', 'type': 'BIOLOGICAL', 'otherNames': ['PRP', 'Platelet Rich Plasma'], 'description': 'Autologous PRP intra ovarian infusion', 'armGroupLabels': ['Participants receiving PRP treatment']}, {'name': 'Placebo-Platelet Free Plasma', 'type': 'BIOLOGICAL', 'otherNames': ['PFP'], 'description': 'Autologous PFP intra ovarian infusion', 'armGroupLabels': ['Participants receiving Platelet Free Plasma (PFP) treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Mara Simopoulou, PhD', 'role': 'CONTACT'}, {'name': 'Agni Pantou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Konstantinos Pantos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Genesis AC', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Mara Simopoulou, PhD', 'role': 'CONTACT', 'email': 'marasimopoulou@hotmail.com', 'phone': '+306979234100'}, {'name': 'Agni Pantou, MD, PhD Candidate', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genesis Athens Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}