Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy
- Conditions
- Primary or Secondary Infertility
- Interventions
- Procedure: IVFProcedure: biopsy
- Registration Number
- NCT01064193
- Lead Sponsor
- University Hospital, Bordeaux
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 190
- primary or secondary infertility
- first or second IVF attempt
- aged ≥18 and ≤38 years
- regular menstrual cycles
- FSH≤ 12IU/L
- Informed consent signed
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 2 IVF fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone group 1 : IVF with biopsy biopsy 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
- Primary Outcome Measures
Name Time Method Rate of clinical pregnancy 5 weeks after the embryo implantation in an IVF procedure
- Secondary Outcome Measures
Name Time Method Adverse effects during the local injury (biopsy) to the endometrium during the biopsy Rate of embryo implantation 5 weeks after the embryo implantation Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy first trimester after the IVF Rate of clinical pregnancy 3 months after the IVF implantation Evaluation of the patients pain intensity and type from the biopsy. during and after the biopsy
Trial Locations
- Locations (3)
CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction
🇫🇷Bordeaux, France
CHU de Toulouse, service de médecine et biologie de la reproduction
🇫🇷Toulouse, France
Cabinet Médical de gynécologie
🇫🇷Pessac, France