Clinical trial NCT03937661: Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
Official title: Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ovary; Anomaly
Infertility, Female
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-05-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 34-36 hours following hCG administration
measure: AMH levels
timeFrame: Follow-up period of three months entailing monthly evaluation
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-7 weeks following last menstruation
measure: Antral Follicle Count
timeFrame: Follow-up period of three months entailing monthly evaluation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Genesis AC
Study officials:
References: