Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy (NIDABRECHE)
Primary Purpose
Primary or Secondary Infertility
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
biopsy
IVF
Sponsored by
About this trial
This is an interventional health services research trial for Primary or Secondary Infertility focused on measuring In Vitro Fertilization, biopsy, pregnancy, Implantation, Embryo, first or second IVF tentative
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
Sites / Locations
- CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction
- Cabinet Médical de gynécologie
- CHU de Toulouse, service de médecine et biologie de la reproduction
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1 : IVF with biopsy
group 2
Arm 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
fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone
Outcomes
Primary Outcome Measures
Rate of clinical pregnancy
Secondary Outcome Measures
Rate of clinical pregnancy
Rate of embryo implantation
Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy
Adverse effects during the local injury (biopsy) to the endometrium
Evaluation of the patients pain intensity and type from the biopsy.
Full Information
NCT ID
NCT01064193
First Posted
February 5, 2010
Last Updated
April 7, 2015
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01064193
Brief Title
Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy
Acronym
NIDABRECHE
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary or Secondary Infertility
Keywords
In Vitro Fertilization, biopsy, pregnancy, Implantation, Embryo, first or second IVF tentative
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1 : IVF with biopsy
Arm Type
Experimental
Arm 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
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
fresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IVF
Intervention Description
fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation
Primary Outcome Measure Information:
Title
Rate of clinical pregnancy
Time Frame
5 weeks after the embryo implantation in an IVF procedure
Secondary Outcome Measure Information:
Title
Rate of clinical pregnancy
Time Frame
3 months after the IVF implantation
Title
Rate of embryo implantation
Time Frame
5 weeks after the embryo implantation
Title
Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy
Time Frame
first trimester after the IVF
Title
Adverse effects during the local injury (biopsy) to the endometrium
Time Frame
during the biopsy
Title
Evaluation of the patients pain intensity and type from the biopsy.
Time Frame
during and after the biopsy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Benard, Doctor
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandrine Blancpain, Doctor
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Cabinet Médical de gynécologie
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CHU de Toulouse, service de médecine et biologie de la reproduction
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy
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