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Endometrial Injury for Assisted Reproduction

This study has been terminated.
(Stopped after safety analysis because of significant benefit of intervention.)
Sponsor:
Collaborators:
FAEPA
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Wellington P Martins, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01132144
First received: May 26, 2010
Last updated: January 2, 2014
Last verified: January 2014

May 26, 2010
January 2, 2014
June 2010
December 2012   (final data collection date for primary outcome measure)
Live Birth [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.

Note: All allocated women will be used as denominator when assessing live birth rate.

  • Pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132144 on ClinicalTrials.gov Archive Site
  • Clinical Pregnancy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.

    Note: All allocated women will be considered when assessing clinical pregnancy rate.

  • Ongoing Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    At least one fetus with heart beat after 12 weeks of gestational age.

    Note: All allocated women will be considered when assessing ongoing pregnancy rate.

  • Miscarriage [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

    Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).

    Note: All allocated women will be considered when assessing miscarriage rate.

  • Implantation Rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The number of gestational sacs observed divided by the number of embryos transferred.
  • Endometrial Thickness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
  • Endometrial Volume [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
  • Three-dimensional Doppler Indices From Endometrium (VFI) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.

    Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.

    Such indices have no scale.

  • Procedure Related Pain [ Time Frame: Immediately after procedure ] [ Designated as safety issue: No ]

    Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: "No Pain" = 0 cm and "Very Severe Pain" = 10 cm.

    This outcome will be assessed in both groups, just after endometrial injury or sham procedure.

  • Endometrial volume change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Three-dimensional sonographic measurement of endometrial volume on the day of hCG indication (in the embryo transfer cycle) minus the endometrial volume on the day of the biopsy (in the previous cycle).
  • Three-dimensional Doppler indices changes of the sub-endometrium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The change in three-dimensional Doppler indices on the day of hCG indication (in the embryo transfer cycle) minus these indices on the day of the endometrial biopsy (in the previous cycle).
  • Multiple pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Abortion rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Endometrial Injury for Assisted Reproduction
Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial

The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infertility
  • Procedure: Endometrial injury

    Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.

    Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.

    Endometrial injury:

    • Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
    • Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
    • Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping.
  • Procedure: Control group
    The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
    Other Name: Sham procedure
  • Experimental: Endometrial injury group
    Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
    Intervention: Procedure: Endometrial injury
  • Sham Comparator: Control group
    Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
    Intervention: Procedure: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
158
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who will start assisted reproductive techniques with planned fresh embryo transfer.
  • Age between 18 and 38 years.
  • Written informed consent.

Exclusion Criteria:

  • None
Female
18 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01132144
HCRP10340/09
No
Wellington P Martins, MD, University of Sao Paulo
University of Sao Paulo
  • FAEPA
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Principal Investigator: Wellington P Martins, PhD Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
University of Sao Paulo
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP