Actively Recruiting
Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion to Improve Ovarian Function in Poor Ovarian Response Patients
Led by Genesis Athens Clinic · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
4 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
The trial investigates the use of autologous platelet rich plasma (PRP) intraovarian infusion to improve ovarian response in women with poor ovarian response (POR) undergoing intracytoplasmic sperm injection (ICSI) treatment. POR is a challenging condition characterized by reduced ovarian reserve and poor stimulation performance, often linked to advanced maternal age, which leads to accelerated follicular loss. This study aims to evaluate the effect of PRP, containing growth factors like VEGF, on restoring ovarian function in a large, well-controlled group of POR patients. Participants are divided into two groups: one receiving autologous PRP intraovarian infusion during the mid-luteal phase followed by a stimulated fresh embryo transfer ICSI cycle the next month, and a control group undergoing the stimulated fresh ET-ICSI cycle without PRP treatment. The PRP is prepared from the participant's own blood and infused into both ovaries via transvaginal ultrasound-guided injection under minimal sedation. During the study, researchers will monitor the number of oocytes retrieved after ovulation triggering and anti-Müllerian hormone levels early in the menstrual cycle post-intervention. Additional assessments include clinical pregnancy rates and antral follicle count. Participants will undergo these evaluations to measure ovarian response and safety, with the study running until early 2026.
CONDITIONS
Brief Title
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with poor ovarian response according to Bologna Criteria, fulfilling at least two of the following: age 40 years or older; anti-Müllerian hormone (AMH) less than 1.1 ng/ml or antral follicle count (AFC) less than 7; three or fewer oocytes retrieved with conventional stimulation
- Discontinued any complementary or adjuvant treatments, including hormone replacement and acupuncture, at least three months before joining
- Willing to comply with all study requirements
You will not qualify if you...
- Any pathological disorder affecting 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 the reproductive system
- Family history of reproductive system cancer
- Severe male factor infertility
- Prior referral for preimplantation genetic testing
- Ovarian inaccessibility or endocrinological disorders including hypothalamus-pituitary issues, thyroid dysfunction, diabetes, or metabolic syndrome
- Body mass index (BMI) over 30 kg/m2 or under 18.5 kg/m2
- Systemic 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 - Approximately 1 month
Participants receive an autologous platelet rich plasma intraovarian infusion during the mid-luteal phase, followed by a stimulated fresh ET-ICSI cycle in the first month after infusion.
1 treatment visit and subsequent stimulation visits
Duration - Up to 7 weeks following last menstruation
Participants are monitored for ovarian function and pregnancy outcomes including oocyte retrieval, hormone levels, and clinical pregnancy.
Visits for assessments at day 2-3 of first menstrual cycle post intervention and 6-7 weeks after last menstruation
Trial Site Locations
Total: 1 location
1
Genesis Athens Clinic
Athens, Attica, Greece, 15232
Actively Recruiting
Research Team
A
Agni Pantou, M.D
K
Konstantinos Pantos, M.D., Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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