## Protocol Section
### Identification Module
**NCT ID:** NCT04363879

**Brief Title:** Comparing Two Types of Endometrial Activation Prior to Embryo Transfer

**Official Title:** Comparing Two Types of Endometrial Activation Prior to Embryo Transfer: A Pilot Study

#### Organization Study ID Info
**ID:** 07-14-06B
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2017-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-20

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-07-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-05-27

**Type:** ACTUAL

**Results First Submit Date:** 2020-04-30

**Results First Submit QC Date:** 2020-05-14

#### Start Date
**Date:** 2014-06-16

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2020-04-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-04-22
**Study First Submit QC Date:** 2020-04-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed Description:** Assisted reproductive technologies (ART), including in vitro fertilization (IVF), are methods used to treat infertility, which affects approximately 10% reproductive aged women. Physicians at the Women's Institute perform over 300 embryo transfer procedures every year. Despite advances and improvements in ART over the past three decades, clinical pregnancy rate and live birth rate remain 30-40% and 20-30%. Implantation is essential for successful ART and IVF procedures, and many interventions have been studied to possibly improve implantation rates and thus pregnancy and live birth rates.

Endometrial activation is one such intervention, sometimes referred to as endometrial "activation" or "scratch," and it is defined as "intentional endometrial injury, such as endometrial biopsy or curettage, in women undergoing ART".

A previous study found that implantation rates, clinical pregnancy rates, and live birth rates were more than twofold higher in women who underwent endometrial biopsy in the cycle before subsequent IVF treatment. Another study which examines endometrial activation prior to IVF similarly has concluded that endometrial activation prior to the embryo transfer cycle significantly improves clinical pregnancy rates and live birth rates in women undergoing ART. Although the type of endometrial procedure is not specified, the timing activation was found be most effective when performed in the cycle prior to the embryo transfer.

The mechanism of increase endometrial receptivity is still unknown; however three proposed hypothesis exist. The first hypothesis proposes that local activation of the endometrium induces endometrial decidualization which increases the probability of embryo implantation. The second hypothesis is that endometrial healing following endometrial activation increases secreted cytokines, interleukins, growth factors, macrophages, and dendritic cells which are beneficial to embryo implantation. The final hypothesis suggests that endometrial maturation is abnormally advanced during ovarian stimulation, so endometrial activation may lead to better synchronicity between the endometrium and the embryo..

Endometrial activation has been found to have clear benefit in pregnancy and live birth rates in a previous study, however no uniform technique has been determined. The objective of this study is to compare two types of endometrial disruption - a vigorous endometrial biopsy with a Pipelle curette and a four quadrant endometrial "scratch" using a Shepard insemination catheter - to determine if the live birth rates are equivalent for the two methods. The investigators also will compare pain with the two types of endometrial activation. By comparing two distinct types of endometrial activation, the goal is to determine which method is both effective and tolerable to patients.

The Shepherd catheter is a 1.8 mm malleable insemination catheter that can be curved to traverse the cervix. It is also used by some physicians in the Women's Institute to perform saline infusion sonography. When the catheter is inserted under ultrasound guidance, it is often placed in the subendometrial tissue, and causes deflection and disruption of the endometrium but is tolerated well. The Pipelle is a 3.1 mm semi-rigid catheter with an internal stylet plunger. A biopsy is performed by placing the catheter into the uterus, withdrawing the stylet to create suction, and aspirating endometrial tissue into the catheter.

A study done by Leclair et al. found that the mean pain that women had when the Pipelle was used for an endometrial biopsy was 6.2±2.4 on a visual analog scale from 1-10 (5). Pain with the Shepard catheter has not been studied when it is used for endometrial biopsy.

### Conditions Module

**Conditions:**

- Infertility

- Endometrial Disorder

**Keywords:**

- Endometrial scratch

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel treatment arms for two types of endometrial scratch

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 195

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Endometrial scratch with Pipelle curette

**Label:** Endometrial scratch with Pipelle curette

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: Endometrial scratch with Shepard catheter

**Label:** Endometrial scratch with Shepard catheter

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Endometrial scratch with Pipelle curette

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

**Name:** Endometrial scratch with Pipelle curette

**Other Names:**

- Endometrial activation, endometrial injury

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Endometrial scratch with Shepard catheter

**Description:** 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.

**Name:** Endometrial scratch with Shepard catheter

**Other Names:**

- Endometrial activation, endometrial injury

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Number of Participants With Live Births Per Transfers Performed

**Time Frame:** Collected up to 1 year after the last embryo transfer

#### Secondary Outcomes

**Description:** Pain assessed by Visual analog scale (Numeric rating scale, units from 1-10 with 1 being no pain and 10 being maximum pain)

**Measure:** Pain Quantifcation After Endometrial Scratch

**Time Frame:** Immediately following endometrial scratch

**Measure:** Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer

**Time Frame:** Collected up to 1 year after the last embryo transfer

**Measure:** Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer

**Time Frame:** Collected up to 1 year after the last embryo transfer

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Brad Hurst, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Kathryn Goldrick, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** We do not plan to share individual patient data with other researchers.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-04-27

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 106448

- Type Abbrev: Prot_SAP

- Upload Date: 2020-04-27T12:14

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** There were no adverse events

#### Event Groups

**Group ID:** EG000

**Title:** Endometrial Scratch With Pipelle Curette

**Deaths Num At Risk:** 78

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

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

**ID:** EG000

**Other Num at Risk:** 78

**Serious Number At Risk:** 78

**Title:** Endometrial Scratch With Pipelle Curette

**Group ID:** EG001

**Title:** Endometrial Scratch With Shepard Catheter

**Deaths Num At Risk:** 92

**Description:** 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.

Endometrial scratch with Shepard catheter: 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.

**ID:** EG001

**Other Num at Risk:** 92

**Serious Number At Risk:** 92

**Title:** Endometrial Scratch With Shepard Catheter

**Frequency Threshold:** 0

**Time Frame:** From start of study until 1 year after last embryo transfer

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 78

**Group ID:** BG001

**Value:** 92

**Group ID:** BG002

**Value:** 170

**Units:** Participants

### Group

**ID:** BG000

**Title:** Endometrial Scratch With Pipelle Curette

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

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

### Group

**ID:** BG001

**Title:** Endometrial Scratch With Shepard Catheter

**Description:** 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.

Endometrial scratch with Shepard catheter: 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.6

**Value:** 33.8

#### Measurement

**Group ID:** BG001

**Spread:** 3.9

**Value:** 34.2

#### Measurement

**Group ID:** BG002

**Spread:** 4.2

**Value:** 34.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 78

**Group ID:** BG001

**Value:** 92

**Group ID:** BG002

**Value:** 170

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 78

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 170

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 78

**Group ID:** BG001

**Value:** 92

**Group ID:** BG002

**Value:** 170

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 75

#### Measurement

**Group ID:** BG002

**Value:** 91

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 62

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 79

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 78

**Group ID:** BG001

**Value:** 92

**Group ID:** BG002

**Value:** 170

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 78

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 170

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 78

**Group ID:** BG001

**Value:** 92

**Group ID:** BG002

**Value:** 170

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** Brad.Hurst@atriumhealth.org
**Organization:** AtriumHealth
**Phone:** 7043553153
**Title:** Dr. Brad Hurst, Director of Assisted Reproduction Program
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 3.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.4
- **Upper Limit:** 
- **Value:** 3.0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number (count) of births per number of subjects undergoing embryo transfer
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Collected up to 1 year after the last embryo transfer
**Title:** Number of Participants With Live Births Per Transfers Performed
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
**ID:** OG000
**Title:** Endometrial Scratch With Pipelle Curette
##### Group
**Description:** 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.

Endometrial scratch with Shepard catheter: 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.
**ID:** OG001
**Title:** Endometrial Scratch With Shepard Catheter
#### Outcome Measure 2
**Description:** Pain assessed by Visual analog scale (Numeric rating scale, units from 1-10 with 1 being no pain and 10 being maximum pain)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Immediately following endometrial scratch
**Title:** Pain Quantifcation After Endometrial Scratch
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
**ID:** OG000
**Title:** Endometrial Scratch With Pipelle Curette
##### Group
**Description:** 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.

Endometrial scratch with Shepard catheter: 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.
**ID:** OG001
**Title:** Endometrial Scratch With Shepard Catheter
#### Outcome Measure 3
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Collected up to 1 year after the last embryo transfer
**Title:** Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer
**Type:** SECONDARY
**Unit of Measure:** positive pregnancy tests
##### Group
**Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
**ID:** OG000
**Title:** Endometrial Scratch With Pipelle Curette
##### Group
**Description:** 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.

Endometrial scratch with Shepard catheter: 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.
**ID:** OG001
**Title:** Endometrial Scratch With Shepard Catheter
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Collected up to 1 year after the last embryo transfer
**Title:** Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer
**Type:** SECONDARY
**Unit of Measure:** number of pregnancies
##### Group
**Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
**ID:** OG000
**Title:** Endometrial Scratch With Pipelle Curette
##### Group
**Description:** 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.

Endometrial scratch with Shepard catheter: 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.
**ID:** OG001
**Title:** Endometrial Scratch With Shepard Catheter
### Participant Flow Module
#### Group
**Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
**ID:** FG000
**Title:** Endometrial Scratch With Pipelle Curette
#### Group
**Description:** 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.

Endometrial scratch with Shepard catheter: 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.
**ID:** FG001
**Title:** Endometrial Scratch With Shepard Catheter
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 78
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 92
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 78
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 92
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True