Primary or Secondary Infertility
Conditions
Keywords
In Vitro Fertilization, biopsy, pregnancy, Implantation, Embryo, first or second IVF tentative
Brief summary
In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.
Detailed description
They are possible mechanisms by which endometrial sampling may increase receptivity and improve clinical pregnancy rate of IVF-ET. First, local injury to proliferative phase endometrium might induce the decidualization of the endometrium, and increase its implantation rate. Second, local injury to the endometrium might provoke the wound healing, involving a mass secretion of different cytokines and growth factor, which are beneficial for embryo implantation. Last, the injury might make the endometrium maturation. This study proposes to evaluate the efficiency of an endometrial injury in the first controlled ovarian hyperstimulation cycle on the rate of clinical pregnancy, in assisted reproductive technologies. This study will compare 2 groups of patients. The first group will undergo biopsy of the endometrium before the IVF; the second will undergo the IVF alone. Inclusions will be conducted on 33 months; the patients will be in the study for a period of 36 weeks. The total duration of the study is 39 months
Interventions
PROCEDUREbiopsy
The endometrium biopsy will be done as the same time as the GnRH treatment. The biopsy is realised with a Pipette de Cornier® (CDD international, PROMIDED France) following the laboratory protocol: * Apply antiseptic solution (povidone-iodine, Dakin®) on the cervix and vagina. In most cases, using Pozzi forceps is not necessary. * Insert carefully the pipelle de Cornier® in the uterus through the cervix. * Withdraw the piston to create a negative pression * Move the pipelle de cornier® in and out while twisting. Take care to no remove the pipelle form the uterus (suction lost). Twist the pipelle de Cornier® to cover an angle of 360°. Make several in and out cycle in order to collect a complete sample of the endometrium. * Withdraw the pipelle de Cornier® when filled with tissue * Reinsert internal piston to deposit sample in cup filled with a fixative.
PROCEDUREIVF
fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* primary or secondary infertility * first or second IVF attempt * aged ≥18 and ≤38 years * regular menstrual cycles * FSH≤ 12IU/L * Informed consent signed
Exclusion criteria
* ovocyte donor * pathology of the uterus or annexes * Body mass index (BMI)\> 35 * ongoing vaginal infection * undetermined vaginal bleeding * contraindication to the Cornier pipette or to these treatments : Gonal F®, Puregon®, Ovitrelle®, Utrogestan®, * women included in another study on medically assisted procreation * any administrative or legal supervision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical pregnancy | 5 weeks after the embryo implantation in an IVF procedure |
Secondary
| Measure | Time frame |
|---|---|
| Rate of clinical pregnancy | 3 months after the IVF implantation |
| Rate of embryo implantation | 5 weeks after the embryo implantation |
| Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy | first trimester after the IVF |
| Adverse effects during the local injury (biopsy) to the endometrium | during the biopsy |
| Evaluation of the patients pain intensity and type from the biopsy. | during and after the biopsy |
Countries
France
Outcome results
None listed