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Endometrial Injury for Assisted Reproduction

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ClinicalTrials.gov Identifier: NCT01132144
Recruitment Status : Terminated (Stopped after safety analysis because of significant benefit of intervention.)
First Posted : May 27, 2010
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Infertility Procedure: Endometrial injury Procedure: Control group Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Study Start Date : June 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Live Birth [ Time Frame: 1 year ]

    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 :
  1. Clinical Pregnancy [ Time Frame: 3 months ]

    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.

  2. Ongoing Pregnancy [ Time Frame: 6 months ]

    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.

  3. Miscarriage [ Time Frame: 9 months ]

    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.

  4. Implantation Rate [ Time Frame: 3 months ]
    The number of gestational sacs observed divided by the number of embryos transferred.

  5. Endometrial Thickness [ Time Frame: 1 month ]
    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.

  6. Endometrial Volume [ Time Frame: 1 month ]
    The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.

  7. Three-dimensional Doppler Indices From Endometrium (VFI) [ Time Frame: 1 month ]

    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.

  8. Procedure Related Pain [ Time Frame: Immediately after procedure ]

    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132144

Setor de Reproducao Humana do HC-FMRP-USP
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
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
More Information

Responsible Party: Wellington P Martins, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01132144     History of Changes
Other Study ID Numbers: HCRP10340/09
First Posted: May 27, 2010    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: January 2014

Keywords provided by Wellington P Martins, MD, University of Sao Paulo:
Reproductive Techniques
Embryo Implantation

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