Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

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.

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Key information

Conditions

Ovarian Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University, Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intra-ovarian platelet rich plasma injection

Other

patients will undergo a transvaginal intra-ovarian platelet rich plasma injection

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Nov 15, 2019
Registry last updated: Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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