Injections of Autologous PRP in Women With Primary Ovarian Insufficiency

NCT03542708 | Completed

• 1 other identifier: 03192018-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. This study will involve only adult women with a diagnosis of POI. Participants will receive injections of autologous PRP in one randomly selected ovary.

Conditions

Primary Ovarian Insufficiency; Premature Menopause

Outcome Measures

Primary Outcomes (1)

• Ovarian Follicles

  Emergence of new ovarian follicles with evidence of estradiol production

  Change from baseline to 12 weeks

Secondary Outcomes (3)

• Increase in serum AMH

  Change from baseline to 12 weeks

• Retrieval of oocytes in an IVF cycle

  6 months

• Clinical Pregnancy

  12 months

Study Arms (2)

A-PRP

EXPERIMENTAL

The cortex of selected ovary will be injected with autologous platelet rich plasma.

Procedure: A-PRP

Control

NO INTERVENTION

The contralateral ovary will not be injected.

Interventions

A-PRP PROCEDURE

The cortex of selected ovary will be injected with autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. The patient will be under IV sedation. Record of which ovary was injected will be kept in the online research database and not in the clinical chart.

Also known as: Autologous Platelet Rich Plasma

A-PRP

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent
• Women 40 years of age and younger with documented primary ovarian insufficiency.
• Normal Karyotype
• FSH \> 30
• AMH not detectable
• No evidence of follicles \> 4mm
• Must have two ovaries of approximately equal volume.
• No Aspirin or any NSAID (e.g. Motrin) for approximately one week before treatment
• Willingness to undergo further fertility treatment, including IVF if there is evidence of response

You may not qualify if:

• Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
• Marked thrombocytopenia
• Blood diseases
• Hypofibrinogenemia
• Hemodynamic instability
• Anticoagulant or antiaggregant treatment
• Oncological diseases (specially, skeletal system and blood)
• Sepsis
• Acute and chronic infectious diseases
• Autoimmune diseases, for example, lupus erythematosus, etc.
• Active substance abuse or dependence
• Major Mental health disorder

Sponsors & Collaborators

• Center for Human Reproduction: lead

Study Sites (1)

Center For Human Reproduction

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Norbert Gleicher, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The care provider will be aware of which ovary is being treated. A different physician will serve as the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One ovary will be randomly selected for treatment with PRP. The other ovary will serve as a control.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: July 25, 2018
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)