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

NCT03945812 | Completed Phase 4 DMC

• 1 other identifier: INDV-0909012
• Study Type: interventional
• Target: 665
• Locations: 1 country
• Sites: 1

Brief 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

Infertility; Frozen Embryo Transfer (FET)

Keywords

GCSF; PRP; Pregnancy

Outcome Measures

Primary Outcomes (1)

• The clinical pregnancy rate

  Definition: The presence of fetal heartbeats in transvaginal ultrasound after 6 to 8 weeks of embryo transfer in all groups. Unit of Measure: The percentage of participants who will achieve a clinical pregnancy among those who underwent the embryo transfer, calculated by dividing the number of participants who will have a clinical pregnancy by the total number of participants who underwent embryo transfer and multiplying by 100.

  6 to 8 weeks of embryo transfer

Secondary Outcomes (10)

• Chemical pregnancy rate

  2 weeks post embryo transfer

• Miscarriage rate

  20 weeks of gestation

• Live-birth rate

  The live birth rate is assessed at the time of birth, including both full-term and preterm live births.

• Implantation rate

  Between 3 and 5 weeks after embryo transfer.

• Endometrial Thickness

  The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).

Study Arms (3)

Granulocyte Colony Stimulating Factor Arm

ACTIVE COMPARATOR

Women in this group will receive GCSF with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.

Drug: Granulocyte Colony Stimulating Factor

Platelet Rich Plasma Arm

ACTIVE COMPARATOR

Women in this group will receive PRP with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.

Other: Platelet Rich Plasma Arm

Saline

PLACEBO COMPARATOR

Women in this group will receive saline with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.

Other: Saline

Interventions

Granulocyte Colony Stimulating Factor DRUG

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

Also known as: Filgrastim

Granulocyte Colony Stimulating Factor Arm

Platelet Rich Plasma Arm OTHER

Platelet Rich Plasma Arm

Platelet Rich Plasma Arm

Saline OTHER

Saline 9%

Also known as: Saline 9%

Saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All women aged 20-40 years
• Non-smoker
• BMI \< 30
• Normal endometrial cavity confirmed by hysteroscopy and ultrasound
• Visiting the center for IVF by FET during the period of the study

You may not qualify if:

• History of anti-phospholipid syndrome confirmed by serological tests.
• History of any hematological and immunological disorders
• History of chromosomal or genetic abnormalities in the patient or in the family
• Any uterine abnormalities (congenital or acquired)
• Previous uterine surgeries except caesarean section
• Hypersensitivity to G-CSF
• Uncontrolled systemic disease

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Hayat center

Maadi, Cairo Governorate, Egypt

Location

Related Publications (4)

• 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.

  PMID: 30859080 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.

  PMID: 24269084 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.

  PMID: 17674185 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.

  PMID: 25785127 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wael SS Elbanna, Consultant

  Wael Elbanna Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 8, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)