Infertility Clinical Trial
Official title:
Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes
Verified date | October 2018 |
Source | Reproductive Medicine Associates of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: |
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey |
United States,
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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