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Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163640
Recruitment Status : Active, not recruiting
First Posted : November 15, 2019
Last Update Posted : March 6, 2023
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Failure Infertility, Female Other: intra-ovarian platelet rich plasma injection Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
Actual Study Start Date : February 24, 2020
Actual Primary Completion Date : August 5, 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection
 Other: intra-ovarian platelet rich plasma injection
patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
No Intervention: Control Group
Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection


Outcome Measures
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Primary Outcome Measures :
  1. number of participants with a mature oocyte retrieved- POI group [ Time Frame: 24 hours post egg retrieval procedure ]
    success or failure is determined by the retrieval of at least one mature oocyte

  2. number of mature oocytes retrieved- POR group [ Time Frame: 24 hours post egg retrieval procedure ]
    the total number of mature oocytes retrieved


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163640


Locations
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United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Turkey
Acibadem University
Istanbul, Turkey
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
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Principal Investigator: Emre U Seli, MD Reproductive Medicine Associates of New Jersey
More Information
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT04163640    
Other Study ID Numbers: RMA-2019-05
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Menopause, Premature
Primary Ovarian Insufficiency
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases