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Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

ConditionsPoor Response to Ovulation InductionInfertility, FemaleOvarian InsufficiencyOvarian FailureReproductive SterilityOvary; Anomaly
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age35-47
SponsorGenesis Athens Clinic

About this trial

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 40 years

AMH < 1.1 ng/ml OR AFC < 7

≤ 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.

Disqualifiers

Any pathological disorder related to reproductive system anatomy

Cycle irregularities

Amenorrhea

Endometriosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous platelet rich plasma

    Biological/Vaccine

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental: Group of participants receiving PRP treatmentExperimental treatment 1 intervention
Group B: Control Group: Group of participants receiving standard protocolNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of oocytes retrieved

Number of oocytes retrieved following controlled ovarian stimulation in the first fresh ICSI-ET cycle performed on the first menstrual cycle following intervention

Time frame
34-36 hours following ovulation triggering
2

Anti-Müllerian Hormone Levels (AMH)

Serum anti-müllerian hormone (AMH) levels evaluated in the first menstrual cycle following intervention

Time frame
On day 2-3 of the first menstrual cycle post intervention

Secondary outcomes

1

Clinical pregnancy rate

Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention

Time frame
6-7 weeks following last menstruation
2

Antral Follicle Count (AFC)

Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention

Time frame
On day 2-3 of the first menstrual cycle post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genesis Athens Clinic

Lead sponsor

National and Kapodistrian University of Athens

Collaborator

Source ClinicalTrials.gov
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