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NCT Number: NCT01798862

Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles

The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

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Key information

Conditions

Repeated Implantation Failures

Age range

25 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital, Athens, Attica, Greece

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About this study

Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Personal history of 2 or more failed IVF/ICSI cycles (RIF)
  • Age</= 42 years
  • Good response with good quality embryos in previous attempts (>2)

Exclusion criteria

  • Personal history of endometrial tuberculosis/ antituberculous treatment
  • Sonographically detected hydrosalpinges
  • Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
  • Thrombophilia

Treatment and study plan

Endometrial injury by hysteroscopy or pipelle sampling

Procedure

Proceed to COH directly

Procedure

Primary outcomes

  1. positive bHCG rate

    Time frame: through study completion, an average of 2 years

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 2 years

  2. live birth rate

    Time frame: 2 years

  3. Ectopic pregnancy rate

    Time frame: 2 years

  4. Miscarriage rate

    Time frame: 2 years

  5. Ongoing pregnancy rate

    Time frame: 2 years

  6. Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2013
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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