Hysteroscopy in Chronic Anovulation

NCT03545945 | Withdrawn

• 1 other identifier: PRO 00034165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Anovulation

Outcome Measures

Primary Outcomes (1)

• Detection of unsuspected underlying uterine abnormalities. (i.e. polyp, fibroids, septum and/or adhesion)

  The primary outcome of the study is to determine whether performing office hysteroscopy in addition to endometrial biopsy in subfertile patients who are at risk of endometrial hyperplasia or cancer, enhances the chances of detection of unsuspected underlying uterine abnormalities. (i.e. polyp, fibroids, septum and/or adhesion).

  1 year

Secondary Outcomes (1)

• Pain score (evaluated on VAS scale)

  1 year

Study Arms (2)

Study arm

EXPERIMENTAL

Patients having office diagnostic hysteroscopy and endometrial biopsy

Procedure: Additional office hysteroscopy; Procedure: Endometrial biopsy

Control arm

OTHER

Patients having only endometrial biopsy

Procedure: Endometrial biopsy

Interventions

Additional office hysteroscopy PROCEDURE

Patients in the study arm will undergo diagnostic office hysteroscopy where they look for any underlying polyp, fibroids or uterine anomaly in addition to endometrial biopsy.

Study arm

Endometrial biopsy PROCEDURE

Patients randomized to endometrial biopsy only group will be prepped with betadine solution and local anesthesia in the form of lidocaine gel placed in the external cervical canal and biopsy will be performed using a Pipelle catheter.

Control arm; Study arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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. -

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida, Department of Obstetrics and Gynecology

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Klip H, Burger CW, Kenemans P, van Leeuwen FE. Cancer risk associated with subfertility and ovulation induction: a review. Cancer Causes Control. 2000 Apr;11(4):319-44. doi: 10.1023/a:1008921211309.

  PMID: 10843444 BACKGROUND

• Legro RS. Diagnostic criteria in polycystic ovary syndrome. Semin Reprod Med. 2003 Aug;21(3):267-75. doi: 10.1055/s-2003-43304.

  PMID: 14593549 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)