Pregnancy Outcomes After Uterine Cavity Expansion

Completed

• Conditions: Uterus Abnormal; Infertility; Miscarriage

• Registration Number: NCT03218878
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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 Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2017-07-21
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy	2 years	presence of a fetal heartbeat at 8 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Chemical pregnancy	2 years	Positive pregnancy test
Ectopic pregnancy	2 years	Pregnancy outside the uterus
Clinical pregnancy	2 years	Presence of a gestational sac on ultrasound
Live birth	2 years	Delivery of a liveborn infant
Obstetrical complications	2 years	Any complications including hypertensive diseases, hemorrhage, etc.
Change in endometrial volume	1 month	Increase or decrease in endometrial volume post-operatively as assessed by saline sonography
Time to conceive	2 years	Time from post-operative visit to conception
Pregnancy loss	2 years	Miscarriage; either biochemical or clinical pregnancy loss
Birthweight	2 years	in grams
Gestational age at delivery	2 years	in weeks and days

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States