Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

ConditionsMenopause, Premature Menopause Related Conditions Menopausal Syndrome Premature Ovarian Failure Ovarian Failure, Premature

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexFemale

Age25-39

SponsorGenesis Athens Clinic

About this trial

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart

Normal Karyotype: 46, XX

Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.

Willing to comply with study requirements

Disqualifiers

Any pathological disorder related to reproductive system anatomy

AMH > 8 pmol/L

Endometriosis

Adenomyosis

Trial design

Design model

Parallel

Treatments tested in this trial

Autologous Platelet Rich Plasma
Biological/Vaccine
Autologous PRP intra ovarian infusion
Placebo-Platelet Free Plasma
Biological/Vaccine
Autologous PFP intra ovarian infusion

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Participants receiving PRP treatmentExperimental treatment 1 intervention

Group B: Participants receiving Platelet Free Plasma (PFP) treatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Restoration of menstrual cycle

Regular menstrual cycle

Time frame

Three months

Serum FSH levels

Serum FSH levels evaluated monthly for three consecutive months

Time frame