NCT02420704

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

April 15, 2015

Last Update Submit

April 18, 2015

Conditions

Keywords

IVFendometrial thicknesscleavage stage embryoblastocyst stage embryoOngoing pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    An ongoing pregnancy was defined as a pregnancy with a positive heartbeat by ultrasound after 12 weeks gestation.

    12 weeks after embryo transfer

Study Arms (6)

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

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

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

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

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

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

Interventions

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 endometrialBlastocyst stage-thick endometrialBlastocyst stage-thin endometrialCleavage stage-medium endometrialCleavage stage-thick endometrialCleavage stage-thin endometrial

Eligibility Criteria

Age22 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • PGD cycles;
  • gamete donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (3)

  • Wu Y, Gao X, Lu X, Xi J, Jiang S, Sun Y, Xi X. Endometrial thickness affects the outcome of in vitro fertilization and embryo transfer in normal responders after GnRH antagonist administration. Reprod Biol Endocrinol. 2014 Oct 9;12:96. doi: 10.1186/1477-7827-12-96.

    PMID: 25296555BACKGROUND
  • Zhao J, Zhang Q, Wang Y, Li Y. Endometrial pattern, thickness and growth in predicting pregnancy outcome following 3319 IVF cycle. Reprod Biomed Online. 2014 Sep;29(3):291-8. doi: 10.1016/j.rbmo.2014.05.011. Epub 2014 Jun 13.

    PMID: 25070912BACKGROUND
  • Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.

    PMID: 24664156BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Yingpu Sun, M.D

    Reproductive Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqin Bu, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medical Center

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 20, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations