Actively Recruiting
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
Led by Genesis Athens Clinic · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
30 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 use of autologous platelet-rich plasma (PRP) intra-ovarian infusion to improve ovarian function in women who have poor ovarian response (POR). This randomized, triple-blind clinical trial evaluates whether PRP can enhance ovarian tissue activity and improve outcomes in fresh embryo transfer (ET) with intracytoplasmic sperm injection (ICSI) cycles. PRP contains growth factors that may stimulate tissue growth and regeneration, but its effect on ovarian rejuvenation and endometrial regeneration is still being explored. Participants are divided into two groups: one receiving autologous PRP intra-ovarian infusion and the other receiving platelet-free plasma (PFP) as a placebo. Both groups undergo a fresh ET-ICSI cycle three months after the infusion. The study includes a follow-up period of three months with monthly evaluations to monitor ovarian response and hormone levels. During the study, participants will have assessments including the number of oocytes retrieved about 34-36 hours after human chorionic gonadotropin (hCG) administration, anti-Müllerian hormone (AMH) levels, and antral follicle count (AFC). Clinical pregnancy rates will be measured 6-7 weeks after the last menstruation. The study involves monitoring safety and efficacy outcomes over the follow-up period, with a total participation window covering the treatment and evaluation phases.
CONDITIONS
Brief Title
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 35 to 47 years
- Poor ovarian response according to Bologna Criteria (meeting 2 of 3: age 6 years, AMH < 1.1 ng/ml or AFC < 7, 3 oocytes with conventional stimulation)
- Discontinued any hormone replacement, acupuncture, or botanotherapy treatments for at least 3 months prior
- Willing to comply with all study requirements
You will not qualify if you...
- Any pathological disorder of reproductive system anatomy
- Irregular menstrual cycles or amenorrhea
- Endometriosis, adenomyosis, fibroids, or adhesions
- Infections in the reproductive system
- Current or past cancer diagnosis related to reproductive system
- 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, metabolic syndrome
- Body mass index (BMI) above 30 or below 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.
Duration - 3 months
Participants receive either autologous PRP intra-ovarian infusion or a placebo infusion and undergo a fresh ET-ICSI cycle three months later.
1 infusion visit and monthly evaluation visits for 3 months
Duration - Approximately 3 months after treatment
Participants are monitored with monthly evaluations including AMH levels and antral follicle count, and clinical pregnancy is assessed 6-7 weeks after last menstruation.
Monthly visits for 3 months and 1 visit at 6-7 weeks after last menstruation
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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