Hysteroscopy in Chronic Anovulation

Withdrawn before enrolling · Not applicable

Conditions studied: Chronic Anovulation

In brief

Patients with chronic anovulation presenting to the IVF clinic for subfertility treatment are at increased risk of endometrial hyperplasia and carcinoma.They are often subjected to endometrial biopsy to rule out any underlying changes such as endometrial hyperplasia or carcinoma before commencing any further treatment. Literature shows that these group of patients have higher possibility of having underlying uterine abnormality (uterine polyp, fibroid, septum, or adhesion) and if we perform only endometrial biopsy, these structural abnormalities will remain undetected. And presence of uterine abnormalities lead to difficulty in implantation, which eventually leads to lower success rate of infertility treatment. WE propose that performing simultaneous office hysteroscopy followed by endometrial biopsy in such patients will lead to higher detection of uterine structural abnormalities and obtaining endometrial tissue to rule out hyperplasia or carcinoma. The concern for clinicians at times is that performing both the procedures together will lead to higher pain perception during the procedure. But with the introduction of flexible hysteroscope which has a diameter of 3.5 mm we hypothesize that the pain of performing office hysteroscopy with endometrial biopsy and performing endometrial biopsy alone will be equivalent. Meanwhile, hysteroscopy will lead lead to detection of underlying uterine pathology and help us in taking directed biopsies.

Key facts

Study ID

NCT03545945

Run by

University of South Florida

People needed

0

Starts

2018-09-01

Expected to finish

2021-03-01

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All consecutive reproductive age female patients (aged 15-45) presenting to IVF clinic for medically indicated endometrial biopsy for evaluation of endometrial pathology with ability to provide written informed consent.
• Sub-fertile women presenting with history of chronic anovulation and in addition meets any one of the criteria mentioned below:
• Women with ≤ 3 menstrual cycle per year.
• Women with oligomenorrhea and BMI >30.
• Women with oligomenorrhea and endometrial thickness >12 mm measured during transvaginal sonography -

You may not qualify if…

• Patients unable to provide informed consent.
• Patients presenting to USF-IVF clinic for evaluation of infertility but endometrial biopsy is not deemed clinically relevant based on assessment by provider.
• Patients refusing participation in lieu of additional procedure.
• Patients are already known to have existing uterine abnormality diagnosed by ultrasound. -

Where it is running

• University of South Florida, Department of Obstetrics and Gynecology — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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