Control Ovarian Stimulation Timing Test (COST2)

March 18, 2015 updated by: Laval University
IVF (in vitro fertilization) cycles fails more often than they succeed. Surprisingly very little effort is invested in defining the reasons for failure and possibly finding ways to improve the success on the next cycle. The investigators believe that the main reasons for failure are related to oocyte quality and indirectly to the follicle response for a particular patient. The investigators have developed a panel of biomarkers to assess the faulty follicular conditions leading to lower oocyte quality. Using these markers would indicate if a given cycle was characterized by over growth, over-luteinization, early or late trigger. Indeed our transcriptomics analysis has identified biomarkers of follicles still in their growth phase at trigger or follicles that have already begun luteinisation compare to follicle that are at the optimal level of differentiation. Measuring these biomarkers would allow making a better diagnostic for a given patient and potentially explaining reasons for failure. The system would also become adjustable to variable COS (control ovarian stimulation) and individual clinical practices. It is important to realize that this is applicable to almost all cycle failure and can be done on a pool of follicular cells when none of the oocytes obtained has led to a pregnancy. This does not resolve uterine problems but often these are caused by hormonal conditions established by the ovary or the ovarian treatment. This technology can be applied in all IVF clinics as no special equipment is required. It would be particularly valuable in clinics where a number of cycles is limited due to funding, or in clinic where a package of 3 cycles is proposed to the patient. The patient interest to have a custom treatment increases at each failing cycle as well as the doctors' interest to succeed. This technology is not clinically validated yet and would require a period of testing where participating clinics will collect the samples for a retrospective analysis (presence of biomarkers of follicular problems vs outcome) then in a prospective analysis where the diagnostic is used in a sub-set of patient to modulate the second/third cycle compared the outcome to patient with no diagnostic. The increase in pregnancy rate or cumulative pregnancy rate should reach a minimum of 10 and 25 % respectively to indicate a significant value.

Study Overview

Status

Unknown

Conditions

Detailed Description

IVF (in vitro fertilization) cycles fails more often than they succeed. Surprisingly very little effort is invested in defining the reasons for failure and possibly finding ways to improve the success on the next cycle. We believe that the main reasons for failure are related to oocyte quality and indirectly to the follicle response for a particular patient. We have developed a panel of biomarkers to assess the faulty follicular conditions leading to lower oocyte quality. Using these markers would indicate if a given cycle was characterized by over growth, over-luteinization, early or late trigger. Indeed our transcriptomics analysis has identified biomarkers of follicles still in their growth phase at trigger or follicles that have already begun luteinisation compare to follicle that are at the optimal level of differentiation. Measuring these biomarkers would allow making a better diagnostic for a given patient and potentially explaining reasons for failure. The system would also become adjustable to variable COS (control ovarian stimulation) and individual clinical practices. It is important to realize that this is applicable to almost all cycle failure and can be done on a pool of follicular cells when none of the oocytes obtained has led to a pregnancy. This does not resolve uterine problems but often these are caused by hormonal conditions established by the ovary or the ovarian treatment.

This technology can be applied in all IVF clinics as no special equipment is required. It would be particularly valuable in clinics where a number of cycles is limited due to funding, or in clinic where a package of 3 cycles is proposed to the patient. The patient interest to have a custom treatment increases at each failing cycle as well as the doctors' interest to succeed.

This technology is not clinically validated yet and would require a period of testing where participating clinics will collect the samples for a retrospective analysis (presence of biomarkers of follicular problems vs outcome).

Five Canadian IVF clinics have agreed to provide a minimum of 200 anonymized samples with information on the cycle/patient medical status. From these samples, RNA will be extracted and the gene expression level will be measured for 3 housekeeping genes and 21 markers derived from previous studies (Hamel et al 2008 and 2010, Nivet et al 2015 submitted).

The genes leading to the best predictive value of negative outcome will then be classified according to our understanding of ovarian physiology as key indicator for generating a diagnostic. The read-outs provided to the clinic would then be one of the 5 following: Too early trigger, too late trigger, too high stimulation (FSH), too high differentiation (LH) or time spread response (a combination of immature and over mature follicles)

Study Type

Observational

Enrollment (Anticipated)

200

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

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

25 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

IVF (In vitro fertilisation) patients infertile patients

Description

Inclusion Criteria:

  • female Infertility

Exclusion Criteria:

  • PCO (polycystic ovary) syndrome women over 42 male factor resulting in sperm samples less than 5 millions motile.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in gene expression levels between pregnant and non pregnant patients (ratio over housekeeping n=3) using 21 biomarkers to assess ovarian stimulation successes.
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Laval University

Collaborators

Merck Serono International SA

Investigators

  • Principal Investigator: Marc Andre Sirard, PhD, Laval University

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

January 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-102

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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