Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorGenesis Athens Clinic
About this trial
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 45-55 years old
Amenorrhea for at least 12 months
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
Previous POI diagnosis
Abnormal karyotype
Endometriosis
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous PRP intra ovarian infusion
Biological/VaccineAutologous PRP intra ovarian infusion
Autologous PFP intra ovarian infusion
Biological/VaccineAutologous PFP intra ovarian infusion
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Participants receiving PRP treatmentExperimental treatment 1 intervention
Group B: Control Group: Participants receiving Platelet Free PlasmaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Restoration of menstrual cycle
Menstrual cycle restoration
Time frame
Three months2
Serum FSH levels
Serum FSH levels evaluated monthly for three consecutive months.
Time frame
Follow-up period of three months entailing monthly evaluationSecondary outcomes
1
Serum AMH levels
Serum AMH levels evaluated monthly for three consecutive months.
Time frame
Follow-up period of three months entailing monthly evaluation2
Serum estradiol levels
Serum estradiol levels evaluated monthly for three consecutive months.
Time frame
Follow-up period of three months entailing monthly evaluation3
Serum LH levels
Serum LH levels evaluated monthly for three consecutive months.
Time frame
Follow-up period of three months entailing monthly evaluation4
Serum progesterone levels
Serum progesterone levels evaluated monthly for three consecutive months.
Time frame
Follow-up period of three months entailing monthly evaluationSponsors 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