Use of GM-CSF Treatment in Recurrent Implantation Failure

Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CONTROL
patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
saline infusion every day from the day of embryo transfer through the day of beta HCG test
Other Names:
  • SALINE INFUSION
Experimental: 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
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
Other Names:
  • GM-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy outcome
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 12 months
number of embryos implanted
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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