Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
NCT ID: NCT05181748
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2019-01-23
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Control Group: Group of participants receiving standard management Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle
TREATMENT
NONE
Study Groups
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Experimental: Group of participants receiving PRP treatment
Women presenting with POR, treated with autologous PRP intraovarian infusion during the mid-luteal phase, undergoing a subsequent stimulated fresh ET-ICSI cycle on the first month following PRP infusion
Autologous platelet rich plasma
Preparation of PRP will be performed immediately following blood sample collection. Blood samples will be collected from the median antebrachial vein. PRP will be prepared according to the manufacturer's instructions employing a Regen Autologous Cellular Regeneration (ACR®-C) Kit (Regen Laboratory, Le Mont-sur-Lausanne, Switzerland). Approximately 60 mL of the patient's peripheral blood will be required in order to yield the required volume of PRP. The goal concentration of platelets in PRP is approximately 1.000.000 platelets/µL. The technique of PRP intraovarian infusion resembles the transvaginal paracentesis performed during the oocyte pick-up procedure. Briefly, both ovaries are visualized via transvaginal ultrasound monitoring, and they are intramedullary injected on multiple sites using a 17-gauge single lumen needle, with the patient under inhaled minimal sedation.
Control Group: Group of participants receiving standard protocol
Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle
No interventions assigned to this group
Interventions
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Autologous platelet rich plasma
Preparation of PRP will be performed immediately following blood sample collection. Blood samples will be collected from the median antebrachial vein. PRP will be prepared according to the manufacturer's instructions employing a Regen Autologous Cellular Regeneration (ACR®-C) Kit (Regen Laboratory, Le Mont-sur-Lausanne, Switzerland). Approximately 60 mL of the patient's peripheral blood will be required in order to yield the required volume of PRP. The goal concentration of platelets in PRP is approximately 1.000.000 platelets/µL. The technique of PRP intraovarian infusion resembles the transvaginal paracentesis performed during the oocyte pick-up procedure. Briefly, both ovaries are visualized via transvaginal ultrasound monitoring, and they are intramedullary injected on multiple sites using a 17-gauge single lumen needle, with the patient under inhaled minimal sedation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 40 years
2. AMH \< 1.1 ng/ml OR AFC \< 7
3. ≤ 3 oocytes with a conventional stimulation protocol
* Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
* Willing to comply with study requirements
Exclusion Criteria
* Cycle irregularities
* 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 Preimplantation Genetic Testing (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
35 Years
47 Years
FEMALE
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Genesis Athens Clinic
OTHER
Responsible Party
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Principal Investigators
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Agni Pantou, M.D
Role: PRINCIPAL_INVESTIGATOR
Genesis Athens Clinic
Locations
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Genesis Athens Clinic
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenesisAC
Identifier Type: -
Identifier Source: org_study_id