Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • live birth rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Ectopic pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Miscarriage rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Ongoing pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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)
Genders 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
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 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
Health Authority: Greece: Ethics Committee of the Attikon University Hospital, Athens
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 October 21, 2016