Pregnancy Outcomes After Uterine Cavity Expansion | NCT03218878

Studies
Pregnancy Outcomes After Uterine Cavity Expansion

NCT03218878

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

Oct 15, 2018Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Miscarriage
Uterus Abnormal
Infertility

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2017Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Sep 10, 2018Actual

First Submitted Date

Jul 13, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2018

Last Update Posted Date

Oct 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study seeks to evaluate pregnancy outcomes following hysteroscopic uterine cavity expansion surgery for patients with dysmorphic uterine cavities and poor reproductive histories. Patients already planning to undergo surgery at the recommendation of their physicians will be recruited for participation.

Detailed Description

Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity at RMANJ is eligible to participate in the study. Patients will be approached for consent to participate in the study prior to undergoing surgery. If enrolled, outcomes following surgery will be followed and recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy	presence of a fetal heartbeat at 8 weeks gestation	2 years

Secondary Outcomes

Measure	Description	Time Frame
Change in endometrial volume	Increase or decrease in endometrial volume post-operatively as assessed by saline sonography	1 month
Time to conceive	Time from post-operative visit to conception

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients at an infertility clinic who are scheduled to undergo hysteroscopic expansion of the uterine cavity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linnea Goodman, MD	Reproductive Medicine Associates of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Associates of New Jersey		Basking Ridge	New Jersey	07920	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000022	Abortion, Spontaneous
C562565	Uterine Anomalies
D007246	Infertility

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided