Effect of Endometrial Thickness on IVF Outcome

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

Effect of Endometrial Thickness on IVF Outcome: a Prospective Observational Study of Both Cleavage Stage and Blastocyst Stage Embryo Transfer Cycles

Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems to have little association with endometrial thickness. Thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

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

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:

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

22 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.

Description

Inclusion Criteria:

  • age between 22-38 years old;
  • the first cycle of IVF treatment with standard long protocol;
  • transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.

Exclusion Criteria:

  • PGD cycles;
  • gamete donation cycles

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cleavage stage-thin endometrial
Patients transferred with cleavage stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
Cleavage stage-medium endometrial
Patients transferred with cleavage stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
Cleavage stage-thick endometrial
Patients transferred with cleavage stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
Blastocyst stage-thin endometrial
Patients transferred with blastocyst stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
Blastocyst stage-medium endometrial
Patients transferred with blastocyst stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
Blastocyst stage-thick endometrial
Patients transferred with blastocyst stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.
Procedure: Embryo transfer
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 12 weeks after embryo transfer
An ongoing pregnancy was defined as a pregnancy with a positive heartbeat by ultrasound after 12 weeks gestation.
12 weeks 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

  • Principal Investigator: Yingpu Sun, M.D, Reproductive Medical Centre

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

November 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 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-Endometrial thickness

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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