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L'essai clinique NCT04278313 (PRP4POA) pour Réserve ovarienne diminuée, Diminished Ovarian Reserve Due to Advanced Maternal Age est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Ovarian Function Following Intraovarian Injection of PRP (PRP4POA)

En recrutement
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L'étude clinique NCT04278313 (PRP4POA) est un essai interventionnel pour Réserve ovarienne diminuée, Diminished Ovarian Reserve Due to Advanced Maternal Age. Son statut actuel est : en recrutement. L'étude a débuté le 24 février 2020 et vise à recruter 90 participants. Dirigé par Center for Human Reproduction, l'essai devrait être terminé d'ici le 30 juin 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 juillet 2024.
Résumé succinct
Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).
Description détaillée
As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.
Titre officiel

Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging

Conditions
Réserve ovarienne diminuéeDiminished Ovarian Reserve Due to Advanced Maternal Age
Autres identifiants de l'essai
  • PRP4POA
  • 02102020-0
Numéro NCT
Date de début (réel)
2020-02-24
Dernière mise à jour publiée
2024-07-10
Date de fin (estimée)
2026-06-30
Inscription (estimée)
90
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Infertility - Ovarian dysfunuction
Diminished Ovarian Reserve
Premature Ovarian Aging (POA)
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Factoriel
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPRP group
Platelet RICH Plasma prepared using RegenLab FDA approved device.
PRP - Platelet Rich Plasma
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
Comparateur placeboPPP group
Platelet POOR Plasma prepared using RegenLab FDA approved device.
PPP - Platelet Poor Plasma
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Embryo Transfer
Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle
6 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Embryos Produced
Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced
6 weeks
AMH
Serum concentration of Anti Mullerian Hormone
4 weeks
Antral Follicle Count
Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses
4 weeks
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
21 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
  • fewer than 6 oocytes in response to past ovulation induction
  • desire to establish a pregnancy using IVF
  • Age 44 years and under.
  • FSH > 12
  • AMH < 1.0
  • No Aspirin or Motrin for one week before treatment

  • Age > 45 years
  • Marked thrombocytopenia
  • Blood diseases
  • Hypofibrinogenemia
  • Hemodynamic instability
  • Anticoagulant or antiaggregant treatment
  • Oncological diseases (specially, skeletal system and blood)
  • Sepsis
  • Acute and chronic infectious diseases
  • Autoimmune diseases, for example, lupus erythematosus, etc.
Center for Human Reproduction logoCenter for Human Reproduction
Contact central de l'essai
Contact: David Barad, MD, 2018417587, [email protected]
Contact: Norbert Gleicher, MD, 212 994-4400, [email protected]
1 Centres de l'essai dans 1 pays

New York

Center for Human Reproduction, New York, New York, 10021, United States
Jolanta Tapper, Contact, 212-994-4400, [email protected]
David Barad, MD, MS, Investigateur principal
Norbert Gleicher, MD, Investigateur associé
En recrutement