Platelet Rich Plasma for Patients With Recurrent Implantation Failure

Infertility Clinical Trial

Official title:

Platelet Rich Plasma for Patients With Recurrent Implantation Failure: A Prospective Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379649
• Other study ID #: 43265
• Status: Completed
• Phase: Early Phase 1
• Start date: January 16, 2019
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Combination Product:
• Platelet rich plasma
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Stanford Fertility and Reproductive Health	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Live birth/embryo transfer	10 months following transfer
Secondary	Pregnancy	Positive pregnancy test/embryo transferred	9 days following transfer