Effects of Embryogen in RIF Patients (RIF)

September 23, 2014 updated by: Dang Quang Vinh, Vietnam National University

Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure

The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 patients with repeated implantation failure were involved.

RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.

Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.

Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam
        • An Sinh Hospital

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal ovarian reserve (AMH > 1.1 ng/ml)
  • Regular menstrual cycle (25 - 34 days)
  • Clear informations about at least 3 latest IVF/ET
  • Fresh embryo transfer in this cycle
  • Endometrial thickness of 10 mm or more

Exclusion Criteria:

  • Undergo oocyte donation or in vitro maturation (IVM) cycles
  • Using frozen or surgically retrieved sperm
  • Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges
  • In participation in other studies/interventions

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GM-CSF
Injected oocytes were cultured in GM-CSF supplemented media until day of transfer
Biological: GM-CSF
2ng/ml of GM-CSF supplemented into culture media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ongoing pregnancy rate
Time Frame: 12 week of gestation
12 week of gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 7 week of gestation
7 week of gestation
clinical pregnancy rate
Time Frame: 7 week of gestation
7 week of gestation
top quality embryo rate
Time Frame: 44 hours after insemination
44 hours after insemination

Collaborators and Investigators

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

Sponsor

Vietnam National University

Investigators

  • Principal Investigator: Vinh Q Dang, Dr, Research Center for Genetics and Reproductive Health

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

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGRH-Embryogen

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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