Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT03951194
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'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': 'D007246', 'term': 'Infertility'}]}}, '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': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restoration of menstrual cycle regularity', '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 AMH 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 etsradiol 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', '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': ['Infertility, Female', 'Perimenopausal Disorder', 'Menstrual Cycle Abnormal']}, 'descriptionModule': {'briefSummary': "Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\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* Amenorrhea\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* Previous POI diagnosis -Endocrinological disorders (Hypothalamus-\n* 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': 'NCT03951194', 'acronym': 'PRP', 'briefTitle': 'Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Genesis Athens Clinic'}, 'officialTitle': 'Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women', 'orgStudyIdInfo': {'id': 'PRP- Perimenopause'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants receiving PRP treatment', 'description': 'Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.', 'interventionNames': ['Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Participants receiving Platelet Free Plasma (PFP)', 'description': 'Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.', 'interventionNames': ['Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion']}], 'interventions': [{'name': 'Autologous Platelet Rich Plasma (PRP) intra ovarian infusion', 'type': 'BIOLOGICAL', 'otherNames': ['PRP', 'Platelet Rich Plasma'], 'description': 'Autologous PRP intra ovarian infusion', 'armGroupLabels': ['Participants receiving PRP treatment']}, {'name': 'Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion', 'type': 'OTHER', 'otherNames': ['PFP', 'Platelet Free Plasma'], 'description': 'Autologous PFP intra ovarian infusion', 'armGroupLabels': ['Participants receiving Platelet Free Plasma (PFP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Agni Pantou, MD, PhD Candidate', 'role': 'CONTACT', 'email': 'agni.pantou@genesisathens.gr'}, {'name': 'Konstantinos Pantos, MD,PhD', 'role': 'CONTACT'}], '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', 'email': 'agni.pantou@genesisathens.gr'}], 'overallOfficials': [{'name': 'Agni Pantou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Obstetrician Gynecologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genesis Athens Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}