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Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI

Primary Purpose

Female , Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
clopidogrel
enoxaparin
placebo
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female , Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Age :20-35yrs.

  1. Embryo transfer at 3rd or 5th day after ovum pick up.
  2. The transferred embryos are in the four cell stage ,eight cell stage, sixteen cell stage or blastocyst stage.

Exclusion Criteria:

  1. Age <20 or >35 yrs old.
  2. Chronic medical disease.
  3. Single embryo transfer.
  4. Previous ICSI failure.

Sites / Locations

  • Ain Shams maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

clopidogrel

enoxaparin

placebo

Arm Description

50 patients undergoing ICSI

50 patients undergoing ICSI

50 patients undergoing ICSI

Outcomes

Primary Outcome Measures

clinical pregnancy
number of participants with positive serum hCG indicating pregnancy

Secondary Outcome Measures

endometrial and subendometrial blood flow
number of participants with improved endometrial and subendometrial blood flow by 2D Doppler ultrasound

Full Information

First Posted
February 12, 2016
Last Updated
February 26, 2016
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02696330
Brief Title
Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI
Official Title
Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female , Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel
Arm Type
Active Comparator
Arm Description
50 patients undergoing ICSI
Arm Title
enoxaparin
Arm Type
Active Comparator
Arm Description
50 patients undergoing ICSI
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
50 patients undergoing ICSI
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
plavix
Intervention Description
clopidogrel 75mg tablets with 300mg loading dose followed by 75mg oral tablets daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Other Intervention Name(s)
clexane
Intervention Description
enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
Primary Outcome Measure Information:
Title
clinical pregnancy
Description
number of participants with positive serum hCG indicating pregnancy
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
endometrial and subendometrial blood flow
Description
number of participants with improved endometrial and subendometrial blood flow by 2D Doppler ultrasound
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age :20-35yrs. Embryo transfer at 3rd or 5th day after ovum pick up. The transferred embryos are in the four cell stage ,eight cell stage, sixteen cell stage or blastocyst stage. Exclusion Criteria: Age <20 or >35 yrs old. Chronic medical disease. Single embryo transfer. Previous ICSI failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Riad, MD
Phone
01005347179
Ext
+2
Email
amr.riad@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams maternity hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI

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