G-CSF and PRP in Patients With Recurrent Implantation Failure

NCT04411212 | Unknown Phase 2 DMC

• 1 other identifier: G-CSF and PRP in RIF
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure

Conditions

Infertility,Female

Keywords

IVF; Platelet-rich plasma; Granulocyte colony-stimulating factor; Recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Gestational sac detected by ultrasound examination

  Five weeks after embryo transfer

Study Arms (2)

Granulocyte colony-stimulating factor and platelet-rich plasma

ACTIVE COMPARATOR

Drug: Granulocyte colony-stimulating factor and platelet-rich plasma group

Control group

OTHER

Other: Control group

Interventions

Granulocyte colony-stimulating factor and platelet-rich plasma group DRUG

Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.

Granulocyte colony-stimulating factor and platelet-rich plasma

Control group OTHER

Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.

Control group

Eligibility Criteria

• Age: 1 Year - 35 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred

You may not qualify if:

• Endometriosis
• Uterine anomalies
• Asherman syndrome

Sponsors & Collaborators

• Riyadh Fertility and Reproductive Health center: lead

Study Sites (1)

Riyadh Fertility and Reproductive Health center

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Granulocyte Colony-Stimulating Factor; Control Groups

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

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; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Usama M Fouda, Prof.

  Riyadh Fertility and Reproductive Health center

  STUDY CHAIR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

+0201095401375; umfrfouda@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: May 28, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)