Actively Recruiting
Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
Led by Genesis Athens Clinic · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
G
Genesis Athens Clinic
Lead Sponsor
N
National and Kapodistrian University of Athens
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of autologous platelet-rich plasma (PRP) intra ovarian infusion to restore ovarian function in menopausal women aged 45 to 55 years. This phase 2 and 3 triple-blind randomized controlled trial explores whether PRP can reactivate the ovaries and promote folliculogenesis, improving hormonal profiles during menopause. PRP contains growth factors that stimulate tissue growth and has been used in other medical fields, but its effect on ovarian rejuvenation is still being studied. Participants are randomly assigned to receive either autologous PRP intra ovarian infusion or a placebo infusion of platelet-free plasma (PFP). Eligible women must have experienced amenorrhea for at least 12 months and stopped any hormone or complementary therapies three months before joining. The treatments are administered directly into the ovaries, and the effects are followed over a three-month period. During the study, participants will undergo monthly evaluations to measure restoration of menstrual cycles and various hormone levels, including FSH, AMH, estradiol, LH, and progesterone. Antral follicle counts will also be monitored to assess ovarian activity. The study aims to collect comprehensive data on ovarian function restoration, with safety and adherence closely observed throughout the trial duration.
CONDITIONS
Brief Title
Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45-55 years old
- Amenorrhea for at least 12 months
- Discontinuation of any complementary or adjuvant treatment including hormone replacement, acupuncture, and botanotherapy for at least three months prior to recruitment
- Willing to comply with study requirements
You will not qualify if you...
- Any pathological disorder related to reproductive system anatomy
- Previous premature ovarian insufficiency (POI) diagnosis
- Abnormal karyotype
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
- Infections in reproductive system
- Current or previous diagnosis of reproductive system cancer
- Family history of reproductive system cancer
- Severe male factor infertility
- Prior referral for preimplantation genetic testing (PGT)
- Ovarian inaccessibility
- Endocrinological disorders including hypothalamus-pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome
- Body mass index (BMI) over 30 kg/m2 or under 18.5 kg/m2
- Systematic autoimmune disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive an autologous PRP or PFP intra ovarian infusion to investigate restoration of ovarian function.
1 visit (in-person)
Duration - 3 months
Participants are monitored monthly to evaluate ovarian function restoration and hormone levels over three months.
Monthly visits for 3 months
Trial Site Locations
Total: 1 location
1
Genesis AC
Athens, Greece, 15232
Actively Recruiting
Research Team
M
Mara Simopoulou, PhD
A
Agni Pantou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here