Completed

NCT Number: NCT01064193

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

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.

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Key information

Conditions

Primary or Secondary Infertility

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction, Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

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.

IVF

Procedure

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

Primary outcomes

Rate of clinical pregnancy

Time frame: 5 weeks after the embryo implantation in an IVF procedure

Secondary outcomes

Rate of clinical pregnancy

Time frame: 3 months after the IVF implantation
Rate of embryo implantation

Time frame: 5 weeks after the embryo implantation
Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy

Time frame: first trimester after the IVF
Adverse effects during the local injury (biopsy) to the endometrium

Time frame: during the biopsy
Evaluation of the patients pain intensity and type from the biopsy.

Time frame: during and after the biopsy

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: NIDABRECHE

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Feb 8, 2010
Registry last updated: Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.