Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy

Study Overview
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Brief Summary
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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
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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

Official Title
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Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART

Conditions
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Primary or Secondary Infertility

Intervention / Treatment
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* Procedure: biopsy
* Procedure: IVF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1 : IVF with biopsy<br>fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation plus local injury to the endometrium of patients one menstrual cycle before the IVF | Procedure: biopsy<br>* 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.<br>|
| Active Comparator: group 2<br>fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone | Procedure: IVF<br>* fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical pregnancy |  | 5 weeks after the embryo implantation in an IVF procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro Fertilization, biopsy, pregnancy, Implantation, Embryo, first or second IVF tentative