Clinical trial NCT01064193: Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary or Secondary Infertility
Keywords: In Vitro Fertilization
biopsy
pregnancy
Implantation
Embryo
first or second IVF tentative
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinical pregnancy
timeFrame: 5 weeks after the embryo implantation in an IVF procedure
Secondary outcomes:
measure: Rate of clinical pregnancy
timeFrame: 3 months after the IVF implantation
measure: Rate of embryo implantation
timeFrame: 5 weeks after the embryo implantation
measure: Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy
timeFrame: first trimester after the IVF
measure: Adverse effects during the local injury (biopsy) to the endometrium
timeFrame: during the biopsy
measure: Evaluation of the patients pain intensity and type from the biopsy.
timeFrame: during and after the biopsy
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction
city: Pessac
country: France
facility: Cabinet Médical de gynécologie
city: Toulouse
country: France
facility: CHU de Toulouse, service de médecine et biologie de la reproduction
Study officials:
affiliation: University Hospital Bordeaux, France
name: Antoine Benard, Doctor
role: STUDY_CHAIR
affiliation: University Hospital Bordeaux, France
name: Sandrine Blancpain, Doctor
role: PRINCIPAL_INVESTIGATOR
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