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Primary or Secondary InfertilityPhase 3NIDABRECHENCT01064193

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

A Phase 3 study testing biopsy and IVF in people with Primary or Secondary Infertility, run by University Hospital, Bordeaux at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 38 years, women only
Conditions the study is for
Primary or Secondary Infertility
What is being tested?
biopsy and IVF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
3 sitesFrance
Study dates
Feb 2010to Feb 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

France3 sites

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

    Bordeaux, 33075

  • Cabinet Médical de gynécologie

    Pessac, 33600

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

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the 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

Being tested
biopsy, IVF
Keywords
In Vitro Fertilization, biopsy, pregnancy, Implantation, Embryo, first or second IVF tentative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biopsyProcedure or surgery

    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.

  • IVFProcedure or surgery

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

Study groups in NCT01064193
Study groupRoleWhat they receive
group 1 : IVF with biopsyExperimentalfresh 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
Receives: Procedure: biopsy
group 2Active comparatorfresh IVF-embryo transfer treated with long protocol or antagonist protocol for the controlled ovarian hyperstimulation alone
Receives: Procedure: IVF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of clinical pregnancy

    Measured: 5 weeks after the embryo implantation in an IVF procedure

Secondary outcomes (5)

  1. Rate of clinical pregnancy

    Measured: 3 months after the IVF implantation

  2. Rate of embryo implantation

    Measured: 5 weeks after the embryo implantation

  3. Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy

    Measured: first trimester after the IVF

  4. Adverse effects during the local injury (biopsy) to the endometrium

    Measured: during the biopsy

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

    Measured: during and after the biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064193
Sponsor's protocol ID
CHUBX 2009/12
Acronym
NIDABRECHE
Status last verified
Apr 2015
First submitted
5 Feb 2010
Last updated
8 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bourgain C, Devroey P. The endometrium in stimulated cycles for IVF. Hum Reprod Update. 2003 Nov-Dec;9(6):515-22. doi: 10.1093/humupd/dmg045.

    PubMed 14714588

  • 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.

    PubMed 17081537

  • 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.

    PubMed 12798877

  • 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.

    PubMed 17197286

  • Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287.

    PubMed 12202415

  • 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.

    PubMed 18054934

  • Khairy M, Banerjee K, El-Toukhy T, Coomarasamy A, Khalaf Y. Aspirin in women undergoing in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril. 2007 Oct;88(4):822-31. doi: 10.1016/j.fertnstert.2006.12.080. Epub 2007 May 16.

    PubMed 17509593

  • Silver MM, Miles P, Rosa C. Comparison of Novak and Pipelle endometrial biopsy instruments. Obstet Gynecol. 1991 Nov;78(5 Pt 1):828-30.

    PubMed 1923207

  • Gellersen B, Brosens IA, Brosens JJ. Decidualization of the human endometrium: mechanisms, functions, and clinical perspectives. Semin Reprod Med. 2007 Nov;25(6):445-53. doi: 10.1055/s-2007-991042.

    PubMed 17960529

  • Lindhard A, Ravn V, Bentin-Ley U, Horn T, Bangsboell S, Rex S, Toft B, Soerensen S. Ultrasound characteristics and histological dating of the endometrium in a natural cycle in infertile women compared with fertile controls. Fertil Steril. 2006 Nov;86(5):1344-55. doi: 10.1016/j.fertnstert.2006.03.052. Epub 2006 Sep 14.

    PubMed 16978615

  • Homburg R, Pap H, Brandes M, Huirne J, Hompes P, Lambalk CB. Endometrial biopsy during induction of ovulation with clomiphene citrate in polycystic ovary syndrome. Gynecol Endocrinol. 2006 Sep;22(9):506-10. doi: 10.1080/09513590600921366.

    PubMed 17071535

  • Sulewski JM, Ward SP, McGaffic W. Endometrial biopsy during a cycle of conception. Fertil Steril. 1980 Dec;34(6):548-51. doi: 10.1016/s0015-0282(16)45193-9.

    PubMed 7450073

  • Wentz AC, Herbert CM 3rd, Maxson WS, Hill GA, Pittaway DE. Cycle of conception endometrial biopsy. Fertil Steril. 1986 Aug;46(2):196-9. doi: 10.1016/s0015-0282(16)49510-5.

    PubMed 3732525

  • Balasch J, Vanrell JA, Marquez M, Gonzalez-Merlo J. Endometrial biopsy inadvertently taken in the cycle of conception. Int J Gynaecol Obstet. 1984 Apr;22(2):95-9. doi: 10.1016/0020-7292(84)90020-1.

    PubMed 6145645

  • Giorgetti C, Terriou P, Auquier P, Hans E, Spach JL, Salzmann J, Roulier R. Embryo score to predict implantation after in-vitro fertilization: based on 957 single embryo transfers. Hum Reprod. 1995 Sep;10(9):2427-31. doi: 10.1093/oxfordjournals.humrep.a136312.

    PubMed 8530679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing biopsy and IVF in people with Primary or Secondary Infertility, run by University Hospital, Bordeaux at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of clinical pregnancy (time frame: 5 weeks after the embryo implantation in an IVF procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064193, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.

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