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Clinical Trials/NCT03218878
NCT03218878CompletedNot Applicable

Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes

Reproductive Medicine Associates of New Jersey1 site in 1 country9 target enrollmentStarted: July 21, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
1
Primary Endpoint
Ongoing pregnancy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ongoing pregnancy

Time Frame: 2 years

presence of a fetal heartbeat at 8 weeks gestation

Secondary Outcomes

  • Chemical pregnancy(2 years)
  • Ectopic pregnancy(2 years)
  • Clinical pregnancy(2 years)
  • Live birth(2 years)
  • Obstetrical complications(2 years)
  • Change in endometrial volume(1 month)
  • Time to conceive(2 years)
  • Pregnancy loss(2 years)
  • Birthweight(2 years)
  • Gestational age at delivery(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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