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

June 8, 2016 updated by: Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 12642
        • Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
    • Thrace
      • Alexandroupolis, Thrace, Greece
        • Assisted Reproduction Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
positive bHCG rate
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 121212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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