Comparing Two Types of Endometrial Activation Prior to Embryo Transfer

NCT04363879 | Completed Results DMC

• 1 other identifier: 07-14-06B
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if two types of endometrial activation (Pipelle curette or Shepard catheter) prior to embryo transfer result in similar live birth rates. Also to determine if patients experience similar pain from both types of endometrial activation.

Conditions

Infertility; Endometrial Disorder

Keywords

Endometrial scratch

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Live Births Per Transfers Performed

  Number (count) of births per number of subjects undergoing embryo transfer

  Collected up to 1 year after the last embryo transfer

Secondary Outcomes (3)

• Pain Quantifcation After Endometrial Scratch

  Immediately following endometrial scratch

• Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer

  Collected up to 1 year after the last embryo transfer

• Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer

  Collected up to 1 year after the last embryo transfer

Study Arms (2)

Endometrial scratch with Pipelle curette

ACTIVE COMPARATOR

For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Procedure: Endometrial scratch with Pipelle curette

Endometrial scratch with Shepard catheter

EXPERIMENTAL

For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.

Procedure: Endometrial scratch with Shepard catheter

Interventions

Endometrial scratch with Pipelle curette PROCEDURE

For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Also known as: Endometrial activation, endometrial injury

Endometrial scratch with Pipelle curette

Endometrial scratch with Shepard catheter PROCEDURE

For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.

Also known as: Endometrial activation, endometrial injury

Endometrial scratch with Shepard catheter

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients undergoing embryo transfer who are in the cycle prior to their embryo transfer

You may not qualify if:

• Patients not undergoing embryo transfer
• Known pregnancy
• Active pelvic infection
• Known endometrial hyperplasia or cancer
• Inability to tolerate endometrial catheter placement
• Severe cervical stenosis
• Patients who will receive operative hysteroscopy in the cycle prior to embryo transfer

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Related Publications (5)

• Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.

  PMID: 23754314 BACKGROUND

• Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

  PMID: 12798877 BACKGROUND

• Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.

  PMID: 25803542 BACKGROUND

• Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b.

  PMID: 21343767 BACKGROUND

• Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.

  PMID: 22786529 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Dr. Brad Hurst, Director of Assisted Reproduction Program
• Organization: AtriumHealth

Brad.Hurst@atriumhealth.org

7043553153

Study Officials

• Brad Hurst, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Kathryn Goldrick, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel treatment arms for two types of endometrial scratch

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 27, 2020
• Study Start: June 16, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 20, 2022
• Results First Posted: May 27, 2020

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share