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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Primary or Secondary Infertility

Treatments: Procedure: biopsy; Procedure: IVF

Study type: Interventional

Funder types: Other

Identifiers

NCT01064193

CHUBX 2009/12

Details and patient eligibility

About

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.

Full 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

Enrollment: 190 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

group 1 : IVF with biopsy

Experimental group

Description:

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

Treatment:

Procedure: biopsy

group 2

Active Comparator group

Description:

fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone

Treatment:

Procedure: IVF