Recruiting

Ovarian Stimulation

Sponsor:

Laval University

Code:

NCT02397135

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 25 - 42

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Infertility

Study ID

NCT02397135

Start date

Jan, 2015

Status verified date

Mar, 2015

Completion date

Sep, 2016

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 42

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Laval University

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

More Information

Sponsor

Laval University

Last update posted

Mar 24, 2015

Last verified

Mar, 2015

Keywords

  • genomic markers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2015-03-24.