PCOS Clinical Trial
Official title:
Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
Evaluation of the endometrial thickness and subendometrial blood perfusion in women with unexplained infertility and PCOS using 3D Power Doppler and uterine artery Doppler in comparison to a control group.
• Background Infertility is a frustrating disease that affects many couples around the world.
Although there are many etiologies responsible for infertility , there are about 15-30 % of
couples who suffer from what is called "Unexplained Infertility". About 25% of infertility is
caused by ovulatory disorders. The World Health Organization (WHO) classifies these ovulatory
disorders into 3 groups. Group II includes women with hypothalamic-pituitary-ovarian
dysfunction (predominately polycystic ovary syndrome (PCOS)) In unexplained infertility,
basic investigations that are done first to reveal the cause of infertility reveal normal
findings. These basic investigations should provide evidence of ovulation, adequate sperm
production and patency of the fallopian tubes.
However, with these routine investigations and even with other more sophisticated
investigations it is hard to reveal all possible abnormalities. Therefore, unexplained
infertility appears to represent either the lower extreme of the normal distribution of
fertility, or it arises from a defect in fecundity that cannot be detected by the routine
infertility evaluation. Couples with unexplained infertility suffer from both diminished and
delayed fecundity.
Due to absence of specific abnormality in cases with unexplained infertility, the management
is usually empiric. Suggested treatment regimens include intrauterine insemination (IUI),
ovulation induction with oral or injectable medications, combination of IUI with ovulation
induction, and assisted reproductive technologies (ART).
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder affecting young women
of reproductive age with the prevalence ranging between 2% to 18% according to different
population and diagnostic criteria. It has been suggested that uterine blood flow is impaired
in women with PCOS.
Ovulation induction (OI) is by far the most commonly used treatment for women with WHO group
II anovulation and clomiphene citrate (CC) has historically been the most used drug In many
fertility guidelines, CC is recommended as the first-line treatment for women with group II
anovulation or PCOS who wish to conceive. However, other guidelines recommend both CC and
letrozole as first-line treatments. It is hypothesized that CC resistance and failure are
related to anti-estrogenic effects of CC on the endometrium, cervical mucus, and uterine
blood flow.
Each month, the human endometrium undergoes a series of distinct cyclical changes in
preparation to receive the developing blastocyst. Such changes necessitate well-controlled
dynamic remodeling of the endometrial microvasculature through the processes of angiogenesis
and arteriogenesis. Abnormalities of endometrial blood perfusion have been associated with
several menstrual disorders including: dysmenorrhea, menorrhagia, intermenstrual bleeding and
endometriosis. So, adequate blood perfusion of the endometrium is considered an important
factor for what is called "endometrial receptivity". So it is possible that women with
unexplained infertility have decreased uterine and endometrial blood perfusion.
Following implantation, there are certain changes that occur in the endometrium and its
vasculature. These changes occur simultaneously with the trophoblastic invasion of the spiral
arteries, and any kind of abnormalities in these changes has been associated with
complications during pregnancy like: recurrent miscarriage, preterm delivery, intrauterine
growth restriction and pre-eclampsia. So, the condition of the endometrium is very essential
for successful implantation of the gestational sac and one of the most important factors
affecting the endometrium is its blood perfusion.
The usual methods of assessment of endometrium like measurement of its thickness and
description of its appearance are considered poor indicators of successful implantation and
pregnancy.Other tools of investigations include: uterine artery Doppler and pulsed wave
Doppler. It was found that information revealed from uterine artery Doppler alone may not
represent the perfusion of the endometrium. Also, pulsed wave Doppler is used to examine the
smaller downstream radial and spiral arteries and this reveals information from single
vessels rather than from the endometrium as a whole. On the other hand, 3D Power Doppler is
claimed to be the best investigatory tool for the study of endometrial blood perfusion as it
is more sensitive to low flow and thus overcomes the problems of angle dependence and
background noise associated with both color and pulsed wave Doppler. In addition, whereas
color Doppler provides qualitative information, the 3D Power Doppler signal can be
subsequently analyzed to produce quantitative information through one of several computer
software packages.
• Hypothesis: Null hypothesis: There is no difference in endometrial thickness, 2D and 3D
Power Doppler indices between normal fertile women, women with unexplained infertility and
women with PCOS.
Alternative hypothesis: There is a difference in endometrial thickness, 2D and 3D Power
Doppler indices between above-mentioned groups.
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