Control Ovarian Stimulation Timing Test
COST2
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 24, 2015
March 1, 2015
8 months
March 5, 2015
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in gene expression levels between pregnant and non pregnant patients (ratio over housekeeping n=3) using 21 biomarkers to assess ovarian stimulation successes.
30 days
Eligibility Criteria
IVF (In vitro fertilisation) patients infertile patients
You may qualify if:
- female Infertility
You may not qualify if:
- PCO (polycystic ovary) syndrome women over 42 male factor resulting in sperm samples less than 5 millions motile.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Merck Serono International SAcollaborator
Study Sites (1)
Laval University
Québec, Quebec, G1V 0A6, Canada
Related Publications (3)
Hamel M, Dufort I, Robert C, Gravel C, Leveille MC, Leader A, Sirard MA. Identification of differentially expressed markers in human follicular cells associated with competent oocytes. Hum Reprod. 2008 May;23(5):1118-27. doi: 10.1093/humrep/den048. Epub 2008 Feb 28.
PMID: 18310048BACKGROUNDHamel M, Dufort I, Robert C, Leveille MC, Leader A, Sirard MA. Genomic assessment of follicular marker genes as pregnancy predictors for human IVF. Mol Hum Reprod. 2010 Feb;16(2):87-96. doi: 10.1093/molehr/gap079. Epub 2009 Sep 24.
PMID: 19778949BACKGROUNDHamel M, Dufort I, Robert C, Leveille MC, Leader A, Sirard MA. Identification of follicular marker genes as pregnancy predictors for human IVF: new evidence for the involvement of luteinization process. Mol Hum Reprod. 2010 Aug;16(8):548-56. doi: 10.1093/molehr/gaq051. Epub 2010 Jul 7.
PMID: 20610614BACKGROUND
Biospecimen
Granulosa cells as aspirated from the pre-ovulatory follicles
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Andre Sirard, PhD
Laval University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 24, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2016
Last Updated
March 24, 2015
Record last verified: 2015-03