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Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

ConditionsOvary; AnomalyInfertility, Female
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age35-47
SponsorGenesis Athens Clinic

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)

Age ≥ 40 years

AMH < 1.1 ng/ml OR AFC < 7

≤ 3 oocytes with a conventional stimulation protocol)

Disqualifiers

Any pathological disorder related to reproductive system anatomy

Cycle irregularities

Amenorrhea

Endometriosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • PRP

    Biological/Vaccine

    Autologous PRP intra ovarian infusion

  • Placebo

    Biological/Vaccine

    Autologous PFP intra ovarian infusion

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group of participants receiving PRP treatmentExperimental treatment 1 intervention
Group B: Control Group: participants receiving Platelet Free PlasmaPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of oocytes retrieved

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

Time frame
34-36 hours following hCG administration
2

AMH levels

Serum AMH levels evaluated monthly for three consecutive months

Time frame
Follow-up period of three months entailing monthly evaluation

Secondary outcomes

1

Clinical pregnancy rate

Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period

Time frame
6-7 weeks following last menstruation
2

Antral Follicle Count

AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

Time frame
Follow-up period of three months entailing monthly evaluation

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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