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Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Primary Purpose

Ovarian Failure, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
intra-ovarian platelet rich plasma injection
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Failure

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria

  1. POI according to ESHRE criteria (patient must fit both criteria):

    1. presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
    2. biochemical confirmation as evidenced by an elevated FSH level >25 IU/L on two occasions > 4 weeks apart
  2. 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)
  3. Patients declining ovum donation treatment

Exclusion criteria

  1. Age <18yo or >38yrs
  2. Autoimmune or sex chromosome etiology of POI
  3. Ongoing malignancy
  4. Previous ovarian surgery
  5. Previous gonadotoxic treatment
  6. Anticoagulant use for which plasma infusion is contraindicated
  7. FMR1 mutations
  8. If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion.
  9. Patients with only 1 ovary
  10. BMI > 35
  11. Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  12. Surgically obtained sperm
  13. Presence of hydrosalpinges that communicate with endometrial cavity
  14. Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
  15. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
  16. Use of a gestational carrier
  17. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
  18. Known ovaries that are not accessible transvaginally.
  19. Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound
  20. FSH > 40iu/l

Sites / Locations

  • Reproductive Medicine Associates of New Jersey
  • Acibadem University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of participants with a mature oocyte retrieved- POI group
success or failure is determined by the retrieval of at least one mature oocyte
number of mature oocytes retrieved- POR group
the total number of mature oocytes retrieved

Secondary Outcome Measures

Full Information

First Posted
November 12, 2019
Last Updated
September 13, 2023
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04163640
Brief Title
Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
Official Title
Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
July 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Failure, Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection
Intervention Type
Other
Intervention Name(s)
intra-ovarian platelet rich plasma injection
Intervention Description
patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
Primary Outcome Measure Information:
Title
number of participants with a mature oocyte retrieved- POI group
Description
success or failure is determined by the retrieval of at least one mature oocyte
Time Frame
24 hours post egg retrieval procedure
Title
number of mature oocytes retrieved- POR group
Description
the total number of mature oocytes retrieved
Time Frame
24 hours post egg retrieval procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria 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 If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion. 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 Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation Known ovaries that are not accessible transvaginally. Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound FSH > 40iu/l
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre U Seli, MD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Acibadem University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

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