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

This study has suspended participant recruitment.
(Study suspended on request of data monitoring comittee in order to analysis the data and efficacy of the research strategy.)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01064193
First received: February 5, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Primary or Secondary Infertility
Procedure: biopsy
Procedure: IVF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Rate of clinical pregnancy [ Time Frame: 5 weeks after the embryo implantation in an IVF procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of clinical pregnancy [ Time Frame: 3 months after the IVF implantation ] [ Designated as safety issue: No ]
  • Rate of embryo implantation [ Time Frame: 5 weeks after the embryo implantation ] [ Designated as safety issue: No ]
  • Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy [ Time Frame: first trimester after the IVF ] [ Designated as safety issue: Yes ]
  • Adverse effects during the local injury (biopsy) to the endometrium [ Time Frame: during the biopsy ] [ Designated as safety issue: Yes ]
  • Evaluation of the patients pain intensity and type from the biopsy. [ Time Frame: during and after the biopsy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 358
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1 : IVF with 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
Procedure: biopsy

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.
Active Comparator: group 2
fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone
Procedure: IVF
fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation

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

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064193

Locations
France
CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction
Bordeaux, France, 33075
Cabinet Médical de gynécologie
Pessac, France, 33600
CHU de Toulouse, service de médecine et biologie de la reproduction
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Antoine Benard, Doctor University Hospital Bordeaux, France
Principal Investigator: Sandrine Blancpain, Doctor University Hospital Bordeaux, France
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01064193     History of Changes
Other Study ID Numbers: CHUBX 2009/12
Study First Received: February 5, 2010
Last Updated: July 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
In Vitro Fertilization
biopsy
pregnancy
Implantation
Embryo
first or second IVF tentative

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 29, 2014