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Completed

NCT Number: NCT03218878

Pregnancy Outcomes After Uterine Cavity Expansion

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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Genital Diseases Infertility Pregnancy Complications Urogenital Diseases Uterine Anomalies Uterus Abnormal

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Ongoing pregnancy

    Time frame: 2 years

    presence of a fetal heartbeat at 8 weeks gestation

Secondary outcomes

  1. Change in endometrial volume

    Time frame: 1 month

    Increase or decrease in endometrial volume post-operatively as assessed by saline sonography

  2. Time to conceive

    Time frame: 2 years

    Time from post-operative visit to conception

  3. Chemical pregnancy

    Time frame: 2 years

    Positive pregnancy test

  4. Clinical pregnancy

    Time frame: 2 years

    Presence of a gestational sac on ultrasound

  5. Pregnancy loss

    Time frame: 2 years

    Miscarriage; either biochemical or clinical pregnancy loss

  6. Ectopic pregnancy

    Time frame: 2 years

    Pregnancy outside the uterus

  7. Live birth

    Time frame: 2 years

    Delivery of a liveborn infant

  8. Obstetrical complications

    Time frame: 2 years

    Any complications including hypertensive diseases, hemorrhage, etc.

  9. Gestational age at delivery

    Time frame: 2 years

    in weeks and days

  10. Birthweight

    Time frame: 2 years

    in grams

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2017
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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