Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Sponsor

Reproductive Medicine Associates of New Jersey (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04163640

Collaborator

(none)

150

Enrollment

Location

Arms

36.2

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Feb 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey	United States	07920

Sponsors and Collaborators

Reproductive Medicine Associates of New Jersey

Investigators

Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reproductive Medicine Associates of New Jersey

ClinicalTrials.gov Identifier:

NCT04163640

Other Study ID Numbers:

RMA-2019-05

First Posted:

Nov 15, 2019

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Menopause, Premature

Primary Ovarian Insufficiency

Study Results

No Results Posted as of Feb 28, 2022