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
  Purpose

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


Condition Intervention Phase
Infertility
Procedure: Endometrial injury
Procedure: Control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 158
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endometrial injury group
Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
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.
Sham Comparator: Control group
Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01132144

Locations
Brazil
Setor de Reproducao Humana do HC-FMRP-USP
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
FAEPA
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Wellington P Martins, PhD Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Wellington P Martins, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01132144     History of Changes
Other Study ID Numbers: HCRP10340/09
Study First Received: May 26, 2010
Results First Received: June 18, 2013
Last Updated: January 2, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Reproductive Techniques
Embryo Implantation
Endometrium
Ultrasonography

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

ClinicalTrials.gov processed this record on September 22, 2014