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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03218878
Other study ID # RMA-2017-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 21, 2017
Est. completion date September 10, 2018

Study information

Verified date October 2018
Source Reproductive Medicine Associates of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date September 10, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Locations

Country Name City State
United States Reproductive Medicine Associates of New Jersey Basking Ridge New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ongoing pregnancy presence of a fetal heartbeat at 8 weeks gestation 2 years
Secondary Change in endometrial volume Increase or decrease in endometrial volume post-operatively as assessed by saline sonography 1 month
Secondary Time to conceive Time from post-operative visit to conception 2 years
Secondary Chemical pregnancy Positive pregnancy test 2 years
Secondary Clinical pregnancy Presence of a gestational sac on ultrasound 2 years
Secondary Pregnancy loss Miscarriage; either biochemical or clinical pregnancy loss 2 years
Secondary Ectopic pregnancy Pregnancy outside the uterus 2 years
Secondary Live birth Delivery of a liveborn infant 2 years
Secondary Obstetrical complications Any complications including hypertensive diseases, hemorrhage, etc. 2 years
Secondary Gestational age at delivery in weeks and days 2 years
Secondary Birthweight in grams 2 years
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