Infertility, Female, Ovary; Anomaly
Conditions
Brief summary
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
Detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on improving ovarian tissue functionality in POR patients.
Interventions
BIOLOGICALPRP
Autologous PRP intra ovarian infusion
BIOLOGICALPlacebo
Autologous PFP intra ovarian infusion
Sponsors
Genesis Athens Clinic
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 47 Years
Healthy volunteers
Yes
Inclusion criteria
* Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following) * Age ≥ 40 years * AMH \< 1.1 ng/ml OR AFC \< 7 * ≤ 3 oocytes with a conventional stimulation protocol) * 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
Exclusion criteria
* Any pathological disorder related to reproductive system anatomy * Cycle irregularities * Amenorrhea * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of cancer in reproductive system * History of familiar cancer in reproductive system * Severe male factor infertility * Prior referral for PGT * Ovarian inaccessibility -Endocrinological disorders (Hypothalamus- * Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) * BMI\>30 kg/m2 or BMI\<18.5 kg/m2 * Systematic autoimmune disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes retrieved | 34-36 hours following hCG administration | Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period |
| AMH levels | Follow-up period of three months entailing monthly evaluation | Serum AMH levels evaluated monthly for three consecutive months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6-7 weeks following last menstruation | Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period |
| Antral Follicle Count | Follow-up period of three months entailing monthly evaluation | AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months |
Countries
Greece
Contacts
CONTACTMara Simopoulou, PhD
CONTACTAgni Pantou, MD, PhD Candidate
Outcome results
None listed