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Hysteroscopy in Chronic Anovulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03545945
Recruitment Status : Unknown
Verified March 2019 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : June 4, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.


Condition or disease Intervention/treatment Phase
Chronic Anovulation Procedure: Additional office hysteroscopy Procedure: Endometrial biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Advantages of Performing Concomitant Office Hysteroscopy and Endometrial Biopsy in Patients With Oligomenorrhea Seeking Infertility Treatment as Compared to Only Endometrial Biopsy: A Prospective Randomized Study
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Study arm
Patients having office diagnostic hysteroscopy and endometrial biopsy
Procedure: Additional office hysteroscopy
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.

Procedure: Endometrial biopsy
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
Patients having only endometrial biopsy
Procedure: Endometrial biopsy
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.




Primary Outcome Measures :
  1. Detection of unsuspected underlying uterine abnormalities. (i.e. polyp, fibroids, septum and/or adhesion) [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Pain score (evaluated on VAS scale) [ Time Frame: 1 year ]
    Our secondary outcome is to compare the pain score (evaluated on VAS scale) between patients who are having office hysteroscopy in addition to endometrial biopsy with patients who are having endometrial biopsy alone (VAS scale).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Women with ≤ 3 menstrual cycle per year.
  2. Women with oligomenorrhea and BMI >30.
  3. Women with oligomenorrhea and endometrial thickness >12 mm measured during transvaginal sonography -

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545945


Contacts
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Contact: Anthony Imudia, MD 2489188592 aimudia@health.usf.edu
Contact: Papri Sarkar, MD 8134098335 paprisarkar2@gmail.com

Locations
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United States, Florida
University of South Florida, Department of Obstetrics and Gynecology Recruiting
Tampa, Florida, United States, 33606
Contact: Linda Odibo, RN, BSc, MSC       lodibo@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03545945    
Other Study ID Numbers: PRO 00034165
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anovulation
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases