Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Endometrial and sub-endometrial blood perfusion expressed as VI, FI VFI.
研究概览
简要总结
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.
详细描述
• 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Inclusion criteria of study group (1&2):
- •Women with primary or secondary infertility for more than 1 year due to unexplained infertility (normal regular menstrual cycles and normal pelvic examination, evidence of ovulation by TV/US and/or normal mid-luteal serum progesterone, normal semen analysis of the husband according to WHO guidlines2010 (25), and evidence of tubal patency and normal uterine cavity by HSG and/or laparoscopy).
- •Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26) • Inclusion criteria for control group (2):
- •Women with no history of menstrual dysfunction or subfertility.
- •Normal regular cycles and normal pelvic examination.
- •Multipara with last delivery since ≥ 2 years with no history of abortions and not on contraception (hormonal or IUD).
排除标准
- •• Exclusion criteria of both groups:
- •History of pelvic surgery or pelvic inflammatory disease.
- •Current hormonal contraception.
- •History of or clinical features suggesting endometriosis or pelvic pathology like uterine fibroid and ovarian cyst.
- •General medical disorders (e.g. D.M), smoking and lactation.
结局指标
主要结局
Endometrial and sub-endometrial blood perfusion expressed as VI, FI VFI.
时间窗: Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Endometrial and sub-endometrial blood perfusion by 3D Power Doppler
Endometrial thickness
时间窗: Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Thickest part of the endometrium in sagittal plane by transvaginal ultrasound
2D Doppler indices of both uterine arteries
时间窗: Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
RI, PI of uterine arteries.
次要结局
- Uterine volume(Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient)
- Demographic characteristics of included women.(Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient)
- Endometrial volume(Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient)
研究者
Moustafa Gadalla
Dr Moustafa Gadalla, Assistant lecturer and specialist of obstetrics and gynecology in school of medicine in Assiut University in Egypt
Assiut University
