Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02696330 |
| Other study ID # |
ICSI |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
February 12, 2016 |
| Last updated |
February 26, 2016 |
| Start date |
September 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
February 2016 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
Amr A Riad, MD |
| Phone |
01005347179 |
| Email |
amr.riad[@]med.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
Egypt: Ministry of Health and Population |
| Study type |
Interventional
|
Clinical Trial Summary
Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI
Description:
Study setting:
Assisted Reproduction unit in Ain Shams University Maternity Hospital
Study population:
Patients underlying ICSI in Assisted Reproduction unit in Ain Shams University maternity
hospital
Intervention:
After taking written informed consent, all patients recruited in the study will undergo,
detailed medical history and complete clinical examination will be obtained along with
necessary laboratory investigations and ultrasound findings The standard protocol of the
Assisted Reproduction unit in Ain Shams University Maternity Hospital for induction of
ovulation in ICSI patients which it is the long protocol will be given for all patients in
the study. Endometrial and sub-endometrial blood flow for every patient in the 3 groups will
be assessed by transvaginal ultrasound using Medison Sonoace R5 ultrasound machine, eight
hours before giving the trigger, after they have completely emptied their bladders (2D power
Doppler will be performed). This will be repeated one week after the day of embryo transfer.
Endometrial blood flow will be detected by intra-endometrial or the adjacent sub-endometrial
regions within 10 mm of the echogenic endometrial borders. Double thickness of the
endometrium will be measured (maximum distance between each myometrial/endometrial interface
through the longitudinal axis of the uterus). The pulsatility index (PI) and resistance
index (RI) of the endometrial arteries will be calculated. Analysis will be used together
with computer algorithms to form indices of blood flow within the endometrium. The
parameters will be analyzed by software for: (i) resistance index (RI): the difference
between maximal systolic blood flow and minimal diastolic flow divided by the peak systolic
flow (S-D/S); (ii) pulsatility index (PI): the difference between maximal systolic blood
flow and minimal diastolic flow divided by the mean flow throughout the cycle (S - D/mean);
(iii) the ratio between peak systolic flow and lowest diastolic flow (S/D). These three
parameters express the resistance to flow from the point of measurement downstream. The
patients will be divided into three groups according to the condition of the endometrial
blood flow: In Group 1, no endometrial blood flow is detected; Group 2 has sub-endometrial
blood flow detected, and Group 3 has both endometrial and sub-endometrial blood flow
detected.
Pregnancy will be assessed by serum B-HCG test after fourteen days of having embryo
transfer, then two weeks later trans-vaginal ultrasound will be performed to insure the
presence of gestational sac.
