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

This study is currently recruiting participants.
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
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
Wounds and Injuries
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 23, 2014