Repeated Embryo Implantation Failure
Conditions
Keywords
Infertility, IVF, Embryo transfer
Brief summary
The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.
Detailed description
Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology. G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving: * Immune tolerance * The self-healing of oocyte chromosome abnormalities * The adherence of the embryo The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.
Interventions
DRUGFilgrastim
The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.
Sponsors
Clinique Ovo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Women between the ages of 18 and 37 * Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer * Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger * Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37. * Negative repetitive implantation failure work up
Exclusion criteria
* Renal failure or cardiac failure * Chronic neutropenia * Past or present cancer history * Sickle cell anemia * Lithium treatment * Voluntary withdrawal from the study * Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of G-CSF | up to 3 years | Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection |
| Pregnancy and Implantation | up to 3 years | Measure the pregnancy and embryo implantation rate post G-CSF injection |
Countries
Canada
Outcome results
None listed