Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders (PRP)
Primary Purpose
Ovary; Anomaly, Infertility, Female
Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
PRP
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ovary; Anomaly
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
Sites / Locations
- Genesis ACRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group of participants receiving PRP treatment
Control Group: participants receiving Platelet Free Plasma
Arm Description
Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.
Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period
Outcomes
Primary Outcome Measures
Number of oocytes retrieved
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
Serum AMH levels evaluated monthly for three consecutive months
Secondary Outcome Measures
Clinical pregnancy rate
Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period
Antral Follicle Count
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months
Full Information
NCT ID
NCT03937661
First Posted
April 23, 2019
Last Updated
February 22, 2023
Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT03937661
Brief Title
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
Acronym
PRP
Official Title
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovary; Anomaly, Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of participants receiving PRP treatment
Arm Type
Experimental
Arm Description
Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.
Arm Title
Control Group: participants receiving Platelet Free Plasma
Arm Type
Placebo Comparator
Arm Description
Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
Autologous PRP intra ovarian infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Autologous PFP intra ovarian infusion
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
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
Time Frame
34-36 hours following hCG administration
Title
AMH levels
Description
Serum AMH levels evaluated monthly for three consecutive months
Time Frame
Follow-up period of three months entailing monthly evaluation
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period
Time Frame
6-7 weeks following last menstruation
Title
Antral Follicle Count
Description
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months
Time Frame
Follow-up period of three months entailing monthly evaluation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mara Simopoulou, PhD
Phone
+306979234100
Email
marasimopoulou@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Agni Pantou, MD, PhD Candidate
Phone
+306974447702
Email
agni.pantou@genesisathens.gr
Facility Information:
Facility Name
Genesis AC
City
Athens
ZIP/Postal Code
15232
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agni Pantou, MD, PhD Candidate
Email
agni.pantou@genesisathens.gr
First Name & Middle Initial & Last Name & Degree
Agni Pantou, MD
First Name & Middle Initial & Last Name & Degree
Konstantinos Pantos, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
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