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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National and Kapodistrian University of Athens
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01798862
First received: February 19, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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
Infertility/ Failed IVF Cycles
Procedure: Endometrial injury by hysteroscopy or pipelle sampling
Procedure: Proceed to COH directly
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: 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 Failed IVF Cycles

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Live Birth Rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Clinical Pregnancy Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Biochemical pregnancy 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 ]

Other Outcome Measures:
  • Positive pregnancy test [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (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.

  Eligibility

Ages Eligible for Study:   25 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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 ClinicalTrials.gov identifier: NCT01798862

Contacts
Contact: Maria Kreatsa, MD, PhD 694-799-6525 ext 0030 mar_kreatsa@yahoo.gr
Contact: Charalampos Siristatidis, Assistant Professor 693-229-4994 ext 0030 harrysiri@yahoo.gr

Locations
Greece
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital Recruiting
Athens, Attica, Greece, 12642
Contact: Maria Kreatsa, MD, PhD    694-799-6525 ext 0030    mar_kreatsa@yahoo.gr   
Sub-Investigator: George Salamalekis, MD, PhD         
Sub-Investigator: Charalampos Chrelias, Assistant Prof OB/GYN         
Sub-Investigator: Tereza Vrantza, MSc         
Sub-Investigator: Paraskevi Vogiatzi, MSc         
Sub-Investigator: Dimitrios Kassanos, Prof OB/GYN         
Assisted Reproduction Unit Not yet recruiting
Alexandroupolis, Thrace, Greece
Contact: Georgios Galazios, Professor       ggalaz@med.duth.gr   
Principal Investigator: Georgios Galazios, Professor OG/GYN         
Sub-Investigator: Nikoletta Koutlaki, Ass Prof OB/GYN         
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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

Publications:
Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01798862     History of Changes
Other Study ID Numbers: 121212
Study First Received: February 19, 2013
Last Updated: November 29, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by National and Kapodistrian University of Athens:
Failed IVF cycles
IVF outcome parameters
endometrial injury
hysteroscopy
pipelle sampling

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

ClinicalTrials.gov processed this record on September 18, 2014