Pregnancy Outcomes After Uterine Cavity Expansion

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218878
• Other study ID #: RMA-2017-04
• Status: Completed
• 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
• 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:

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Infertility
• Miscarriage
• Uterus Abnormal

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