Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women

ConditionsInfertility, Female Perimenopausal Disorder Menstrual Cycle Abnormal

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexFemale

Age40-50

SponsorGenesis Athens Clinic

About this trial

Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.

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

Amenorrhea

Endometriosis

Adenomyosis

Trial design

Design model

Parallel

Treatments tested in this trial

Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
Biological/Vaccine
Autologous PRP intra ovarian infusion
Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Other intervention
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)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

Restoration of menstrual cycle regularity

Regular Menstrual cycle

Time frame

Three months

Serum FSH levels

Serum FSH levels evaluated monthly for three consecutive months.

Time frame