Chronic AnovulationNCT03545945
Hysteroscopy in Chronic Anovulation
A study testing Additional office hysteroscopy and Endometrial biopsy in people with Chronic Anovulation, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Anovulation
- What is being tested?
- Additional office hysteroscopy and Endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida, Department of Obstetrics and Gynecology
Tampa, Florida, 33606
About this study
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
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.
Read the detailed description
Patients with subfertility due to hormonal disorders are at increased risk of endometrial cancer and hyperplasia . Such conditions are associated with chronic anovulation, obesity and/or hyperinsulinemia. Presumably, the mechanism relates to constant, unrelenting estrogen stimulation of the endometrium, predisposing to abnormal patterns of growth. Hence, patients with long standing anovulation presenting for infertility evaluation, are often subjected to endometrial biopsy to rule out any underlying hyperplasia or malignancy.
The polycystic ovary syndrome (PCOS) is the most obvious and common condition associated with chronic anovulation. It is characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphologic features. Based on National Institutes of Health (i.e. hyperandrogenism plus ovulatory dysfunction), "classic" polycystic ovary syndrome affects 10% of women of reproductive age but the prevalence may be twice under the broader Rotterdam criteria . Women with PCOS are at increased risk of infertility, endometrial hyperplasia and cancer. The risk of endometrial cancer in a woman with PCOS is reported to be 2.7 times higher than someone without this syndrome. Other uncommon conditions associated with chronic anovulation are Cushing's syndrome, congenital adrenal hyperplasia secondary to 21 hydroxylase deficiency, thyroid or liver disorder leading to decreased clearance of estrogen from the body. Similarly, obese postmenopausal women are also at increased risk for developing endometrial cancer.
In these patients, elevated plasma levels of androgen precursors increase estrogen level through aromatization of androgens in adipose tissue. In addition, it has been seen that non cycling patients with grossly increased endometrial thickness (greater than 12 mm) are also at high risk of endometrial hyperplasia. So these are the indications, which warrants patients to undergo endometrial biopsy. Literature shows that the prevalence of minor intrauterine abnormalities identified at hysteroscopy in cases with a normal transvaginal sonography (TVS) can be as high as 20-40%. Similarly, the prevalence of unsuspected uterine cavity abnormalities, diagnosed in an unselected group of patients undergoing IVF can be 11%. In this study, they identified endometrial polyps in 6% women, submucous myomas in 1%, intrauterine adhesions (2%), and septa (2%) . Another study also reports 16% intracavitary lesion in patients with infertility. It has been seen that in an IVF population, obesity (BMI >30) is also an independent risk factor for developing endometrial polyps. The prevalence of polyps in patients with BMI > 30 is 52% as compared to 15% among patients with BMI <30. Similarly, PCOS patients also show a higher incidence of endometrial polyp (29%) diagnosed by hysteroscopy as compared to the nonPCOS population and the presence of 2 or more such polyps is associated with significant premalignant or malignant condition. So, missing the diagnosis of polyps in PCOS patients renders them to higher risk of developing malignancy in future. With this background, an important clinical question is if it is clinically justified to combine office hysteroscopy and endometrial biopsy as part of the comprehensive evaluation of these patients? It is possible that prompt diagnosis and treatment of these unsuspected uterine abnormalities could optimize the condition of the uterine environment and thereby the outcome of treatment.
In spite of all the advantages office hysteroscopy offers, one of the reasons for avoiding office hysteroscopy has been the apprehension that adding office hysteroscopy will lead to higher pain score. But based on our literature review we propose that adding flexible office hysteroscopy to endometrial biopsy will not lead to any increase in pain score. In routine practice, endometrial biopsy is usually performed with "Pipelle" and is a simple office procedure. It is an excellent tool for evaluating the histopathology of the endometrium. The mean pain score during endometrial biopsy is 3 in a VAS scale of 1-10 with only 6.7% patients reporting severe pain . In a more recent study, the pain score during endometrial biopsy has been reported to be 6.2, which is higher than the previous reports. Similarly, office hysteroscopy is also a simple procedure with high patient acceptability and safety. The pain score reported during office hysteroscopy using flexible scope range from 2.3 -3. During traditional hysteroscopy where speculum and tenaculum is used, the pain score has been reported to be as high as 5.3. In fact, a comparative study of endometrial biopsy and office hysteroscopy showed that the pain score is higher during endometrial biopsy (5.1) as compared to diagnostic hysteroscopy (2.7). Hence, it seems very reasonable to add office hysteroscopy to endometrial biopsy for patients undergoing endometrial evaluation. This combined approach will have better diagnostic yield without increasing the pain perception.
- Conditions
- Chronic Anovulation
- Being tested
- Additional office hysteroscopy, Endometrial biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional office hysteroscopyProcedure or surgery
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.
Endometrial biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients having office diagnostic hysteroscopy and endometrial biopsy Receives: Procedure: Additional office hysteroscopy; Procedure: Endometrial biopsy |
| Control arm | Other | Patients having only endometrial biopsy Receives: Procedure: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
Pain score (evaluated on VAS scale)
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021
Why it stopped: Unable to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic AnovulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545945
- Sponsor's protocol ID
- PRO 00034165
- Status last verified
- Mar 2019
- First submitted
- 22 May 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10843444Legro RS. Diagnostic criteria in polycystic ovary syndrome. Semin Reprod Med. 2003 Aug;21(3):267-75. doi: 10.1055/s-2003-43304.
PubMed 14593549
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03545945
- Acronym / sponsor ID
- PRO 00034165
- Conditions
- Chronic Anovulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with subfertility due to hormonal disorders are at increased risk of endometrial cancer and hyperplasia . Such conditions are associated with chronic anovulation, obesity and/or hyperinsulinemia. Presumably, the mechanism relates to constant, unrelenting estrogen stimulation of the endometrium, predisposing to abnormal patterns of growth. Hence, patients with long standing anovulation presenting for infertility evaluation, are often subjected to endometrial biopsy to rule out any underlying hyperplasia or malignancy.
The polycystic ovary syndrome (PCOS) is the most obvious and common condition associated with chronic anovulation. It is characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphologic features. Based on National Institutes of Health (i.e. hyperandrogenism plus ovulatory dysfunction), "classic" polycystic ovary syndrome affects 10% of women of reproductive age but the prevalence may be twice under the broader Rotterdam criteria . Women with PCOS are at increased risk of infertility, endometrial hyperplasia and cancer. The risk of endometrial cancer in a woman with PCOS is reported to be 2.7 times higher than someone without this syndrome. Other uncommon conditions associated with chronic anovulation are Cushing's syndrome, congenital adrenal hyperplasia secondary to 21 hydroxylase deficiency, thyroid or liver disorder leading to decreased clearance of estrogen from the body. Similarly, obese postmenopausal women are also at increased risk for developing endometrial cancer.
In these patients, elevated plasma levels of androgen precursors increase estrogen level through aromatization of androgens in adipose tissue. In addition, it has been seen that non cycling patients with grossly increased endometrial thickness (greater than 12 mm) are also at high risk of endometrial hyperplasia. So these are the indications, which warrants patients to undergo endometrial biopsy. Literature shows that the prevalence of minor intrauterine abnormalities identified at hysteroscopy in cases with a normal transvaginal sonography (TVS) can be as high as 20-40%. Similarly, the prevalence of unsuspected uterine cavity abnormalities, diagnosed in an unselected group of patients undergoing IVF can be 11%. In this study, they identified endometrial polyps in 6% women, submucous myomas in 1%, intrauterine adhesions (2%), and septa (2%) . Another study also reports 16% intracavitary lesion in patients with infertility. It has been seen that in an IVF population, obesity (BMI >30) is also an independent risk factor for developing endometrial polyps. The prevalence of polyps in patients with BMI > 30 is 52% as compared to 15% among patients with BMI <30. Similarly, PCOS patients also show a higher incidence of endometrial polyp (29%) diagnosed by hysteroscopy as compared to the nonPCOS population and the presence of 2 or more such polyps is associated with significant premalignant or malignant condition. So, missing the diagnosis of polyps in PCOS patients renders them to higher risk of developing malignancy in future. With this background, an important clinical question is if it is clinically justified to combine office hysteroscopy and endometrial biopsy as part of the comprehensive evaluation of these patients? It is possible that prompt diagnosis and treatment of these unsuspected uterine abnormalities could optimize the condition of the uterine environment and thereby the outcome of treatment.
In spite of all the advantages office hysteroscopy offers, one of the reasons for avoiding office hysteroscopy has been the apprehension that adding office hysteroscopy will lead to higher pain score. But based on our literature review we propose that adding flexible office hysteroscopy to endometrial biopsy will not lead to any increase in pain score. In routine practice, endometrial biopsy is usually performed with "Pipelle" and is a simple office procedure. It is an excellent tool for evaluating the histopathology of the endometrium. The mean pain score during endometrial biopsy is 3 in a VAS scale of 1-10 with only 6.7% patients reporting severe pain . In a more recent study, the pain score during endometrial biopsy has been reported to be 6.2, which is higher than the previous reports. Similarly, office hysteroscopy is also a simple procedure with high patient acceptability and safety. The pain score reported during office hysteroscopy using flexible scope range from 2.3 -3. During traditional hysteroscopy where speculum and tenaculum is used, the pain score has been reported to be as high as 5.3. In fact, a comparative study of endometrial biopsy and office hysteroscopy showed that the pain score is higher during endometrial biopsy (5.1) as compared to diagnostic hysteroscopy (2.7). Hence, it seems very reasonable to add office hysteroscopy to endometrial biopsy for patients undergoing endometrial evaluation. This combined approach will have better diagnostic yield without increasing the pain perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: Additional office hysteroscopy, Procedure: Endometrial biopsyPatients having office diagnostic hysteroscopy and endometrial biopsy |
| Control arm | Other | Procedure: Endometrial biopsyPatients having only endometrial biopsy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional office hysteroscopyPatients 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 or surgery | Study arm |
| Endometrial biopsyPatients 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. | Procedure or surgery | Control arm, Study arm |
Primary outcome
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).
1 secondary outcome
Pain score (evaluated on VAS scale)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 10843444Klip 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.
- Background: PubMed 14593549Legro RS. Diagnostic criteria in polycystic ovary syndrome. Semin Reprod Med. 2003 Aug;21(3):267-75. doi: 10.1055/s-2003-43304.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional office hysteroscopy and Endometrial biopsy in people with Chronic Anovulation, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of unsuspected underlying uterine abnormalities. (i.e. polyp, fibroids, septum and/or adhesion) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.