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Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

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ClinicalTrials.gov Identifier: NCT04163640
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Tracking Information
First Submitted Date  ICMJE November 12, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE February 24, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
  • 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
  • number of mature oocytes retrieved- POR group [ Time Frame: 24 hours post egg retrieval procedure ]
    the total number of mature oocytes retrieved
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
Official Title  ICMJE Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Failure
  • Infertility, Female
Intervention  ICMJE Other: intra-ovarian platelet rich plasma injection
patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
Study Arms  ICMJE
  • Experimental: Intervention Group
    Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection
    Intervention: Other: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine V Whitehead, BSN, RN 973-656-2841 clinicalresearchteam@ivirma.com
Contact: Caroline Zuckerman, BS 973-656-2841 clinicalresearchteam@ivirma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04163640
Other Study ID Numbers  ICMJE RMA-2019-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reproductive Medicine Associates of New Jersey
Study Sponsor  ICMJE Reproductive Medicine Associates of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
PRS Account Reproductive Medicine Associates of New Jersey
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP