PCOS Clinical Trial
Official title:
Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
NCT number | NCT03397693 |
Other study ID # | 17200152 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2018 |
Est. completion date | May 20, 2019 |
Verified date | June 2019 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 20, 2019 |
Est. primary completion date | April 20, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - • Inclusion criteria of study group (1&2): 1. 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). 2. Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26) • Inclusion criteria for control group (2): 1. Women with no history of menstrual dysfunction or subfertility. 2. Normal regular cycles and normal pelvic examination. 3. Multipara with last delivery since = 2 years with no history of abortions and not on contraception (hormonal or IUD). Exclusion Criteria: - • Exclusion criteria of both groups: 1. History of pelvic surgery or pelvic inflammatory disease. 2. Current hormonal contraception. 3. On IUD. 4. History of or clinical features suggesting endometriosis or pelvic pathology like uterine fibroid and ovarian cyst. 5. General medical disorders (e.g. D.M), smoking and lactation. |
Country | Name | City | State |
---|---|---|---|
Egypt | Department of Obstetrics and Gynecology, School of Medicine, Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endometrial thickness | Thickest part of the endometrium in sagittal plane by transvaginal ultrasound | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient | |
Primary | Endometrial and sub-endometrial blood perfusion expressed as VI, FI VFI. | Endometrial and sub-endometrial blood perfusion by 3D Power Doppler | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient | |
Primary | 2D Doppler indices of both uterine arteries | RI, PI of uterine arteries. | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient | |
Secondary | Demographic characteristics of included women. | Demographic characteristics of included women. | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient | |
Secondary | Endometrial volume | Using VOCAL software during transvaginal ultrasound examination | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient | |
Secondary | Uterine volume | Using VOCAL software during transvaginal ultrasound examination | Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient |
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