Back to resultsPlatelet Rich Plasma for Patients With Recurrent Implantation Failure
Primary Purpose
Infertility
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Recurrent implantation failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Stanford Fertility and Reproductive HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRP
Placebo
Arm Description
Patient with recurrent implantation failure who receives intrauterine infusion of platelet rich plasma
Patient with recurrent implantation failure who receives intrauterine infusion of embryo culture media
Outcomes
Primary Outcome Measures
Live birth rate
Live birth/embryo transfer
Secondary Outcome Measures
Pregnancy
Positive pregnancy test/embryo transferred
Full Information
NCT ID
NCT03379649
First Posted
December 15, 2017
Last Updated
December 7, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT03379649
Brief Title
Platelet Rich Plasma for Patients With Recurrent Implantation Failure
Official Title
Platelet Rich Plasma for Patients With Recurrent Implantation Failure: A Prospective Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patients considered to have recurrent implantation failure will undergo randomization to receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media prior to their embryo transfer. All patients will undergo a blood draw to obtain 60ml of blood from which 0.5ml of platelet rich plasma will be obtained. Those randomized to receive the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at least 48 hours prior to the embryo transfer, while those randomized to receive placebo will have embryo culture media placed into the uterine cavity at the same point in time. Those randomized to the placebo group will have the opportunity to be placed into the treatment group if no pregnancy was attained. Transfer outcomes including implantation rate, pregnancy rate, and live birth rate, will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Recurrent implantation failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Patients will be blinded to the treatment they received, but providers and investigators will be aware.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Experimental
Arm Description
Patient with recurrent implantation failure who receives intrauterine infusion of platelet rich plasma
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient with recurrent implantation failure who receives intrauterine infusion of embryo culture media
Intervention Type
Combination Product
Intervention Name(s)
Platelet rich plasma
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live birth rate
Description
Live birth/embryo transfer
Time Frame
10 months following transfer
Secondary Outcome Measure Information:
Title
Pregnancy
Description
Positive pregnancy test/embryo transferred
Time Frame
9 days following transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lusine Aghajanova, M.D.
Phone
650-498-7911
Email
aghajano@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lusine Aghajanova, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Fertility and Reproductive Health
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27921085
Citation
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.
Results Reference
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Platelet Rich Plasma for Patients With Recurrent Implantation Failure
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