Platelet-Rich Plasma vs. Granulocyte Colony-Stimulating Factor vs. Placebo and Outcomes in Frozen Embryo Transfer

Summary

The goal of this clinical trial is to assess the impact of using Platelet-Rich Plasma (PRP) vs. Granulocyte Colony-Stimulating Factor (GCSF) vs. placebo on the outcomes of frozen embryo transfer (FET) in terms of clinical pregnancy rates. It will also assess their effect on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters. The main questions it aims to answer are: Do the clinical pregnancy rates differ upon using PRP vs. GCSF vs. placebo during FET? What are the effects of PRP vs. GCSF vs. placebo during FET on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters? Researchers will compare the effect of administration of PRP vs. GCSF vs. placebo during FET on pregnancy outcomes. Participants will be randomized to receive the study intervention seven days before embryo transfer: 1.0 ml of either PRP (prepared in-house), GCSF (Filgrastim, 300 mcg/1.0 mL), or 0.9% saline (placebo). The intervention will be administered by slow infusion into the uterine cavity with an intrauterine insemination catheter.

Timeline

Start

2019-06-01

Primary completion

2022-03-31

Completion

2023-03-08

Publications

• Background Mehrafza M, Kabodmehri R, Nikpouri Z, Pourseify G, Raoufi A, Eftekhari A, Samadnia S, Hosseini A. Comparing the Impact of Autologous Platelet-rich Plasma and Granulocyte Colony Stimulating Factor on Pregnancy Outcome in Patients with Repeated Implantation Failure. J Reprod Infertil. 2019 Jan-Mar;20(1):35-41.
• Background Coughlan C, Ledger W, Wang Q, Liu F, Demirol A, Gurgan T, Cutting R, Ong K, Sallam H, Li TC. Recurrent implantation failure: definition and management. Reprod Biomed Online. 2014 Jan;28(1):14-38. doi: 10.1016/j.rbmo.2013.08.011. Epub 2013 Sep 14.
• Background Rinehart J. Recurrent implantation failure: definition. J Assist Reprod Genet. 2007 Jul;24(7):284-7. doi: 10.1007/s10815-007-9147-4. Epub 2007 Aug 3.
• Background Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.

Drugs

Indications