Implantation Prediction by Three Dimensional (3D) Ultrasound in Fresh Embryo Transfers

NCT02817373 | Unknown DMC

• 1 other identifier: 123-16MMC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to predict implantation of a fresh, high quality embryo in an in vitro fertilization (IVF) cycle by using ultrasound based uterine factors.

Conditions

Infertility

Keywords

IVF; embryo transfer; ultrasound; implantation

Outcome Measures

Primary Outcomes (1)

• implantation of a fresh high quality embryo

  Implantation is defined as the presence of a gestational sac as will be assessed by a vaginal ultrasound probe 4 weeks after the embryo transfer. Implantation is expected to exist only in cases of a positive pregnancy test; in such cases the ultrasound can either describe an absence of sac, a single sac or multiple sacs.

  outcome measure will be known within 4 weeks of the embryo transfer

Study Arms (1)

transvaginal ultrasound study

OTHER

Patients with a well established infertility requiring IVF treatment and who are \<40. Cohort will consist of patients going through a fresh day 5 transfer with a planned transfer of a single good quality embryo. Patients will go thorough a Ultrasound scan performed through a vaginal probe on the morning of the embryo transfer.

Other: Ultrasound scan performed through a vaginal probe

Interventions

Ultrasound scan performed through a vaginal probe OTHER

5-8 minute scan recording : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area

transvaginal ultrasound study

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single day 5 fresh embryo transfer of good quality
• Age\<40

You may not qualify if:

• Frozen embryo transfer
• Age\>40
• Day 2-3 transfer
• Double embryo transfer

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, Israel

RECRUITING

Related Publications (3)

• Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.

  PMID: 8970487 BACKGROUND

• Matsuura K, Hayashi N, Takiue C, Hirata R, Habara T, Naruse K. Blastocyst quality scoring based on morphologic grading correlates with cell number. Fertil Steril. 2010 Aug;94(3):1135-7. doi: 10.1016/j.fertnstert.2009.11.003. Epub 2010 Jan 15.

  PMID: 20079898 RESULT

• Hershko-Klement A, Tepper R. Ultrasound in assisted reproduction: a call to fill the endometrial gap. Fertil Steril. 2016 Jun;105(6):1394-1402.e4. doi: 10.1016/j.fertnstert.2016.04.012. Epub 2016 Apr 29.

  PMID: 27140291 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Amir Wiser, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Hershko Klement, MD

CONTACT

972549170084; anat.klement@gmail.com

Amir Wiser, MD

CONTACT

97297472901; amir.wiser@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 29, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)