Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-02 @ 3:46 AM
Study NCT ID:
NCT03937661
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '34-36 hours following hCG administration', 'description': 'Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period'}, {'measure': 'AMH levels', 'timeFrame': 'Follow-up period of three months entailing monthly evaluation', 'description': 'Serum AMH levels evaluated monthly for three consecutive months'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6-7 weeks following last menstruation', 'description': 'Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period'}, {'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': ['Ovary; Anomaly', 'Infertility, Female']}, 'descriptionModule': {'briefSummary': "Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).", '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 fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 POR patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)\n* Age ≥ 40 years\n* AMH \\< 1.1 ng/ml OR AFC \\< 7\n* ≤ 3 oocytes with a conventional stimulation protocol)\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* Cycle irregularities\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 -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': 'NCT03937661', 'acronym': 'PRP', 'briefTitle': 'Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders', 'organization': {'class': 'OTHER', 'fullName': 'Genesis Athens Clinic'}, 'officialTitle': 'Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders', 'orgStudyIdInfo': {'id': 'PRP - poor responders'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group of participants receiving PRP treatment', 'description': 'Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.', 'interventionNames': ['Biological: PRP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group: participants receiving Platelet Free Plasma', 'description': 'Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'Autologous PRP intra ovarian infusion', 'armGroupLabels': ['Group of participants receiving PRP treatment']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Autologous PFP intra ovarian infusion', 'armGroupLabels': ['Control Group: participants receiving Platelet Free Plasma']}]}, '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': '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', 'email': 'agni.pantou@genesisathens.gr', 'phone': '+306974447702'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genesis Athens Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}