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

This study has been completed.
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens Identifier:
First received: February 19, 2013
Last updated: June 8, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Repeated Implantation Failures
Procedure: Endometrial injury by hysteroscopy or pipelle sampling
Procedure: Proceed to COH directly
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • positive bHCG rate [ Time Frame: through study completion, an average of 2 years ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ]
  • live birth rate [ Time Frame: 2 years ]
  • Ectopic pregnancy rate [ Time Frame: 2 years ]
  • Miscarriage rate [ Time Frame: 2 years ]
  • Ongoing pregnancy rate [ Time Frame: 2 years ]
  • Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA) [ Time Frame: 2 years ]

Enrollment: 100
Study Start Date: March 2013
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endometrial injury by hysteroscopy or pipelle sapling
Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
Procedure: Endometrial injury by hysteroscopy or pipelle sampling
Active Comparator: COH for IVF without hysteroscopy or pipelle sampling
Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied.
Procedure: Proceed to COH directly

Detailed Description:
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.

Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01798862

Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, Greece, 12642
Assisted Reproduction Unit
Alexandroupolis, Thrace, Greece
Sponsors and Collaborators
National and Kapodistrian University of Athens
Principal Investigator: Maria Kreatsa, MD/PhD National and Kapodistrian University of Athens
Principal Investigator: Charalampos Siristatidis, MD, PhD National Kapodistrian University of Athens
  More Information

Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction, National and Kapodistrian University of Athens Identifier: NCT01798862     History of Changes
Other Study ID Numbers: 121212
Study First Received: February 19, 2013
Last Updated: June 8, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by National and Kapodistrian University of Athens:
Failed IVF cycles
IVF outcome parameters
endometrial injury
pipelle sampling
Repeated implantation failures processed this record on April 26, 2017