The Effectiveness of Endometrial Injury in IVF

April 18, 2015 updated by: Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

The Effectiveness of Endometrial Injury in Different Phase of Menstrual Cycle:a Prospective Controlled Clinical Study

Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current cycle. However, few studies have compared the effectiveness of those two different endometrial scratch methods performed in different timing. The aim of this study is to find the best timing of endometrial scratch in FET cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
        • Contact:
          • Yang Wang, M.D

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • To be aged younger than 40 years old;
  • At least one period IVF-ET (fresh or thaw) has been done and not pregnant after at least one qualified blastocyst (more than 3BB) or two qualified embryos (more than II/6) have been transferred;
  • There are qualified embryos thawed and the thaw-ET period will be taken.

Exclusion Criteria:

  • Malformation of uterus: such as uterus uni-corns, uterus bi-corns, untreated uterus septus, etc.;
  • History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.;
  • Multiple myomata or endometrioma which causes uterus oppression;
  • Multiple and recurrent endometrial polyps;
  • Pelvic tuberculosis, endometriosis.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Young age group-Luteal phase
Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Procedure: endometrial scratch
local injury to the endometrium by Pipelle
Other Names:
  • endometrial injury
Active Comparator: Young age group-Early follicular phase
Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Procedure: endometrial scratch
local injury to the endometrium by Pipelle
Other Names:
  • endometrial injury
Experimental: Advanced age group-Luteal phase
Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Procedure: endometrial scratch
local injury to the endometrium by Pipelle
Other Names:
  • endometrial injury
Active Comparator: Advanced age group-Early follicular phase
Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Procedure: endometrial scratch
local injury to the endometrium by Pipelle
Other Names:
  • endometrial injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 35 days after embryo transfer
See heart beat with ultrasonic exam.
35 days after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ectopic pregnancy rate
Time Frame: 35 days after embryo transfer
No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level
35 days after embryo transfer

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Study Chair: Yingpu Sun, MD,PhD, Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

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

February 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 18, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMCZZU-EEI

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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