NCT03937661

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

5.7 years

First QC Date

April 23, 2019

Last Update Submit

December 20, 2024

Conditions

Ovary; AnomalyInfertility, Female

Outcome Measures

Primary Outcomes (2)

  • 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

    34-36 hours following hCG administration

  • AMH levels

    Serum AMH levels evaluated monthly for three consecutive months

    Follow-up period of three months entailing monthly evaluation

Secondary Outcomes (2)

  • Clinical pregnancy rate

    6-7 weeks following last menstruation

  • Antral Follicle Count

    Follow-up period of three months entailing monthly evaluation

Study Arms (2)

Group of participants receiving PRP treatment

EXPERIMENTAL

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.

Biological: PRP

Control Group: participants receiving Platelet Free Plasma

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

PRPBIOLOGICAL

Autologous PRP intra ovarian infusion

Group of participants receiving PRP treatment
PlaceboBIOLOGICAL

Autologous PFP intra ovarian infusion

Control Group: participants receiving Platelet Free Plasma

Eligibility Criteria

Age35 Years - 47 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesis AC

Athens, 15232, Greece

RECRUITING

MeSH Terms

Conditions

Congenital AbnormalitiesInfertility, Female

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Mara Simopoulou, PhD

CONTACT

+306979234100marasimopoulou@hotmail.com

Agni Pantou, MD, PhD Candidate

CONTACT

+306974447702agni.pantou@genesisathens.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

May 6, 2019

Study Start

May 6, 2019

Primary Completion

January 30, 2025

Study Completion

August 30, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

GR(1)