Pregnancy Outcomes After Uterine Cavity Expansion

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Miscarriage; Uterus Abnormal

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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Associates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	2 years
Chemical pregnancy	Positive pregnancy test	2 years
Clinical pregnancy	Presence of a gestational sac on ultrasound	2 years
Pregnancy loss	Miscarriage; either biochemical or clinical pregnancy loss	2 years
Ectopic pregnancy	Pregnancy outside the uterus	2 years
Live birth	Delivery of a liveborn infant	2 years
Obstetrical complications	Any complications including hypertensive diseases, hemorrhage, etc.	2 years
Gestational age at delivery	in weeks and days	2 years
Birthweight	in grams	2 years

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Linnea Goodman, MD, Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Infertility; Abortion, Spontaneous
• Other Study ID Numbers: RMA-2017-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No