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

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ClinicalTrials.gov Identifier: NCT01798862
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Repeated Implantation Failures Procedure: Endometrial injury by hysteroscopy or pipelle sampling Procedure: Proceed to COH directly Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  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 ]

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

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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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): NCT01798862


Locations
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Greece
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
Investigators
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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
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Publications of Results:

Other Publications:

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Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01798862    
Other Study ID Numbers: 121212
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens:
Failed IVF cycles
IVF outcome parameters
endometrial injury
 hysteroscopy
pipelle sampling
Repeated implantation failures