Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female; Ovarian Failure
• Intervention / Treatment: Other: intra-ovarian platelet rich plasma injection

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: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Acibadem University
• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Associates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Emre U Seli, MD, Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Primary Ovarian Insufficiency; Menopause, Premature; Infertility, Female
• Other Study ID Numbers: RMA-2019-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No