Use of GM-CSF Treatment in Recurrent Implantation Failure

Phase 3

• Conditions: Women With Recurrent Implantation Failure in IVF
• Interventions: Drug: CONTROL; Drug: GM-CSF group

• Registration Number: NCT01715974
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary

The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.

Detailed Description

The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.

The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.

Study Timeline

• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-29
• Study Start: 2017-12-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• women 50 years old or less with three or more previous egg donation cycles failed,
• with a total of at least 4 blastocysts replaced in uterus

Exclusion Criteria

• chromosomal defects in the patients,
• metabolic diseases (diabetes etc.)
• genetic diseases (thalassemia, cystic fibrosis, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	CONTROL	patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
GM-CSF group	GM-CSF group	patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test

Primary Outcome Measures

Name	Time	Method
pregnancy outcome	12 months	The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group

Secondary Outcome Measures

Name	Time	Method
implantation rate	12 months	number of embryos implanted

Trial Locations

Locations (1)

Cerm-Hungaria; 🇮🇹 Rome, Italy