Actively Recruiting
Investigating Autologous PRP Intra-ovarian Infusion to Restore Ovarian Function and Promote Follicle Growth in Premature Ovarian Failure
Led by Genesis Athens Clinic · Updated on 2024-12-24
100
Participants Needed
1
Research Sites
365 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 studying the effect of autologous platelet-rich plasma (PRP) intra-ovarian infusion on women with premature ovarian insufficiency (POI). This trial is a triple-blind randomized controlled study aiming to see if PRP can reactivate ovarian function and promote the growth of ovarian follicles. PRP contains growth factors that stimulate tissue growth and has been used in other medical fields, but its effectiveness for ovarian rejuvenation and endometrial regeneration is not yet fully known. Participants receive either an infusion of their own platelet-rich plasma or a placebo infusion of platelet-free plasma directly into the ovaries. The study compares these two groups to evaluate the impact of PRP on restoring ovarian tissue function. Treatments are administered during the trial period, and participants are monitored closely for changes. During the study, women's menstrual cycles and hormone levels, particularly serum follicle-stimulating hormone (FSH), are assessed monthly over a three-month follow-up. Researchers measure restoration of menstrual cycles and hormonal improvements as primary outcomes. Participants comply with study requirements and attend scheduled evaluations to track progress and safety throughout the trial.
CONDITIONS
Official Title
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age under 40 years with amenorrhea or irregular menstrual cycles for at least four months
- Elevated FSH levels above 25 IU/L on two occasions more than 4 weeks apart
- Normal karyotype 46, XX
- Discontinued hormone replacement, acupuncture, botanotherapy, or other complementary treatments for at least three months before recruitment
- Willingness to comply with all study requirements
You will not qualify if you...
- Any anatomical disorder of the reproductive system
- Anti-Mullerian Hormone (AMH) levels above 8 pmol/L
- Endometriosis or adenomyosis
- Presence of fibroids or adhesions
- Infections in the reproductive system
- Current or past cancer diagnosis in the reproductive system
- Family history of reproductive system cancer
- Severe male factor infertility
- Prior referral for preimplantation genetic testing (PGT)
- Inaccessibility of the ovaries
- Endocrinological disorders including hypothalamus-pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome
- Body mass index (BMI) over 30 or under 18.5 kg/m2
- Systematic autoimmune disorders
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Trial Site Locations
Total: 1 location
1
Genesis AC
Athens, Greece, 15232
Actively Recruiting
Research Team
M
Mara Simopoulou, PhD
A
Agni Pantou, MD, PhD Candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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