Hysteroscopy in Chronic Anovulation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/24/2019 |
| Start Date: | September 1, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Anthony Imudia, MD |
| Email: | aimudia@health.usf.edu |
| Phone: | 2489188592 |
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.
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.
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.
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.
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. -
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