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

NCT03945812 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Granulocyte Colony Stimulating Factor

Filgrastim, Amgen, California, USA 300 mg/1.0 mL

OTHER

Platelet Rich Plasma Arm

Platelet Rich Plasma Arm

OTHER

Saline

Saline 9%

Sponsors & Collaborators

  • National Research Centre, Egypt

    collaborator OTHER

  • Wael Elbanna Clinic

    lead OTHER

Principal Investigators

  • Wael SS Elbanna, Consultant · Wael Elbanna Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2022-03-31
Completion
2023-03-08

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945812 on ClinicalTrials.gov