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

NCT01064193 | Completed Phase 3

• 1 other identifier: CHUBX 2009/12
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary or Secondary Infertility

Keywords

In Vitro Fertilization; biopsy; pregnancy; Implantation; Embryo; first or second IVF tentative

Outcome Measures

Primary Outcomes (1)

• Rate of clinical pregnancy

  5 weeks after the embryo implantation in an IVF procedure

Secondary Outcomes (5)

• Rate of clinical pregnancy

  3 months after the IVF implantation

• Rate of embryo implantation

  5 weeks after the embryo implantation

• Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy

  first trimester after the IVF

• Adverse effects during the local injury (biopsy) to the endometrium

  during the biopsy

• Evaluation of the patients pain intensity and type from the biopsy.

  during and after the biopsy

Study Arms (2)

group 1 : IVF with biopsy

EXPERIMENTAL

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

group 2

ACTIVE COMPARATOR

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

Procedure: IVF

Interventions

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.

group 1 : IVF with biopsy

IVF PROCEDURE

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

group 2

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• primary or secondary infertility
• first or second IVF attempt
• aged ≥18 and ≤38 years
• regular menstrual cycles
• FSH≤ 12IU/L
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

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

Bordeaux, 33075, France

Location

Cabinet Médical de gynécologie

Pessac, 33600, France

Location

CHU de Toulouse, service de médecine et biologie de la reproduction

Toulouse, 31059, France

Location

Related Publications (27)

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  PMID: 14714588 BACKGROUND

• Richter KS, Bugge KR, Bromer JG, Levy MJ. Relationship between endometrial thickness and embryo implantation, based on 1,294 cycles of in vitro fertilization with transfer of two blastocyst-stage embryos. Fertil Steril. 2007 Jan;87(1):53-9. doi: 10.1016/j.fertnstert.2006.05.064. Epub 2006 Nov 1.

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• Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

  PMID: 12798877 BACKGROUND

• Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.

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• Revelli A, Dolfin E, Gennarelli G, Lantieri T, Massobrio M, Holte JG, Tur-Kaspa I. Low-dose acetylsalicylic acid plus prednisolone as an adjuvant treatment in IVF: a prospective, randomized study. Fertil Steril. 2008 Nov;90(5):1685-91. doi: 10.1016/j.fertnstert.2007.08.037. Epub 2007 Dec 11.

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  PMID: 7450073 BACKGROUND

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  PMID: 17681303 BACKGROUND

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  PMID: 30496529 DERIVED

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine Benard, Doctor

  University Hospital Bordeaux, France

  STUDY CHAIR

• Sandrine Blancpain, Doctor

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

FR (3)