NCT04163640

Brief Summary

The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.4 years

First QC Date

November 12, 2019

Last Update Submit

September 13, 2023

Conditions

Ovarian FailureInfertility, Female

Outcome Measures

Primary Outcomes (2)

  • number of participants with a mature oocyte retrieved- POI group

    success or failure is determined by the retrieval of at least one mature oocyte

    24 hours post egg retrieval procedure

  • number of mature oocytes retrieved- POR group

    the total number of mature oocytes retrieved

    24 hours post egg retrieval procedure

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection

Other: intra-ovarian platelet rich plasma injection

Control Group

NO INTERVENTION

Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection

Interventions

intra-ovarian platelet rich plasma injectionOTHER

patients will undergo a transvaginal intra-ovarian platelet rich plasma injection

Intervention Group

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • POI according to ESHRE criteria (patient must fit both criteria):
  • presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
  • biochemical confirmation as evidenced by an elevated FSH level \>25 IU/L on two occasions \> 4 weeks apart
  • POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
  • Patients declining ovum donation treatment

You may not qualify if:

  • Age \<18yo or \>38yrs
  • Autoimmune or sex chromosome etiology of POI
  • Ongoing malignancy
  • Previous ovarian surgery
  • Previous gonadotoxic treatment
  • Anticoagulant use for which plasma infusion is contraindicated
  • FMR1 mutations
  • Patients with only 1 ovary
  • BMI \> 35
  • Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  • Surgically obtained sperm
  • Presence of hydrosalpinges that communicate with endometrial cavity
  • Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
  • Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
  • Use of a gestational carrier
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Acibadem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Herlihy NS, Cakiroglu Y, Whitehead C, Reig A, Tiras B, Scott RT Jr, Seli E. Effect of intraovarian platelet-rich plasma injection on IVF outcomes in women with poor ovarian response: the PROVA randomized controlled trial. Hum Reprod. 2024 May 9:deae093. doi: 10.1093/humrep/deae093. Online ahead of print.

    PMID: 38725194DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Emre U Seli, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

February 24, 2020

Primary Completion

August 5, 2022

Study Completion

July 21, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)TU(1)