Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Not Applicable

Completed

• Conditions: Infertility, Female; Ovarian Failure
• Interventions: Other: intra-ovarian platelet rich plasma injection

• Registration Number: NCT04163640
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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 Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-15
• Study Start: 2020-02-24
• Primary Completion: 2022-08-05
• Study Completion: 2023-07-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
number of participants with a mature oocyte retrieved- POI group	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	24 hours post egg retrieval procedure	the total number of mature oocytes retrieved

Trial Locations

Locations (2)

Acibadem University; 🇹🇷 Istanbul, Turkey

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States