Platelet Rich Plasma for Patients With Recurrent Implantation Failure

NCT03379649 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: 43265
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. Platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. We hope to conduct a randomized controlled pilot study to determine whether PRP is indeed an effective treatment for recurrent implantation failure.

Conditions

Infertility

Keywords

Recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Live birth/embryo transfer

  10 months following transfer

Secondary Outcomes (1)

• Pregnancy

  9 days following transfer

Study Arms (2)

PRP

EXPERIMENTAL

Patient with recurrent implantation failure who receives intrauterine infusion of platelet rich plasma

Combination Product: Platelet rich plasma

Placebo

PLACEBO COMPARATOR

Patient with recurrent implantation failure who receives intrauterine infusion of embryo culture media

Combination Product: Placebo

Interventions

Platelet rich plasma COMBINATION_PRODUCT

Patients will have 60ml of blood drawn. Platelet rich plasma will be obtained by placing the blood in the Arteriocyte Magellan device. 0.5ml of Platelet rich plasma will be placed into the uterus at least 48 hours prior to embryo transfer.

PRP

Placebo COMBINATION_PRODUCT

Patients will have 60ml of blood drawn. 0.5ml of embryo culture media (the placebo) will be placed into the uterus at least 48 hours prior to embryo transfer.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All women who have undergone 3 or more embryo (blastocyst stage) transfers without establishing a clinical pregnancy or 2 or more euploid embryo transfers without establishing a clinical pregnancy, aged 18 - 45, with a normal uterine cavity established within 12 months by hysteroscopy or saline infusion sonogram, planning in vitro fertilization with an embryo transfer at Stanford Fertility and Reproductive Health. The planned transfer must consist of any of the following: a PGS proven euploid embryo, a good quality blastocyst from a patient younger than 37, or a donor oocyte blastocyst.

You may not qualify if:

• Abnormal uterine cavity, planning in vitro fertilization with use of a gestational carrier. patients enrolled in other experimental interventions for RIF will be excluded. Patients with only poor quality or cleavage stage embryos.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Fertility and Reproductive Health

Sunnyvale, California, 94087, United States

Location

Related Publications (2)

• Nazari L, Salehpour S, Hoseini S, Zadehmodarres S, Ajori L. Effects of autologous platelet-rich plasma on implantation and pregnancy in repeated implantation failure: A pilot study. Int J Reprod Biomed. 2016 Oct;14(10):625-628.

  PMID: 27921085 BACKGROUND

• Aghajanova L, Strug M, Zhang J, Lathi RB. Intrauterine platelet-rich plasma infusion for recurrent implantation failure: a pilot randomized controlled single-blinded clinical trial in the USA. J Assist Reprod Genet. 2025 Nov 17. doi: 10.1007/s10815-025-03752-7. Online ahead of print.

  PMID: 41247443 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lusine Aghajanova, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Patients will be blinded to the treatment they received, but providers and investigators will be aware.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: January 16, 2019
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)