ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments

September 17, 2012 updated by: Biogenesi

Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Implantation Failure

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss.

Couples requiring IVF treatment and with a past experience of implantation failure will be included in the study.

Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.

Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • Biogenesi Reproductive Medicine Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile couple with an indication for standard IVF or intracytoplasmic sperm injection. Moreover all couples had previous implantation failures after ART treatment (minimun 2 maximun 4 embryo replacements).

Description

Inclusion Criteria:

  • women experiencing at least two (maximum 4) failures of implantation after ART treatments (with elective embryo transfer)

Exclusion Criteria:

  • Frozen spermatozoa
  • Frozen oocytes
  • women PCO and PCOS
  • women with previous pregnancy, miscarriage or biochemical pregnancy

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

Cohorts and Interventions

Group / Cohort
IVF treatment ISM1
Embryo culture in ISM1 medium
IVF treatment EG
Embryo culture in EmbryoGen medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing Pregnancy Rate after 12 weeks of gestation
Time Frame: 12 weeks after conception
12 weeks after conception

Secondary Outcome Measures

Outcome Measure
Time Frame
Ongoing Implantation Rate after 12 weeks of gestation
Time Frame: 12 weeks after conception
12 weeks after conception

Collaborators and Investigators

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

Sponsor

Biogenesi

Investigators

  • Principal Investigator: Mariabeatrice Dal Canto, PhD, Biogenesi Reproductive Medicine Centre

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.

General Publications

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

September 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 21, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EG48BSept12
  • EG2 (Other Identifier: Biogenesi Reproductive Medicine Centre)

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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