NCT03218878

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

July 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

July 13, 2017

Last Update Submit

October 11, 2018

Conditions

MiscarriageUterus AbnormalInfertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    presence of a fetal heartbeat at 8 weeks gestation

    2 years

Secondary Outcomes (10)

  • Change in endometrial volume

    1 month

  • Time to conceive

    2 years

  • Chemical pregnancy

    2 years

  • Clinical pregnancy

    2 years

  • Pregnancy loss

    2 years

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

MeSH Terms

Conditions

Abortion, SpontaneousUterine AnomaliesInfertility

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Linnea Goodman, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 17, 2017

Study Start

July 21, 2017

Primary Completion

September 1, 2018

Study Completion

September 10, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

US(1)