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

NCT ID: NCT02696330

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Female , Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

clopidogrel

50 patients undergoing ICSI

Group Type: ACTIVE_COMPARATOR

clopidogrel

Intervention Type: DRUG

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

enoxaparin

50 patients undergoing ICSI

Group Type: ACTIVE_COMPARATOR

enoxaparin

Intervention Type: DRUG

enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound

placebo

50 patients undergoing ICSI

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound

Interventions

clopidogrel

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

enoxaparin

enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound

Intervention Type: DRUG

placebo

starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound

Intervention Type: DRUG

Other Intervention Names

plavix; clexane

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amr Ahmed Mahmoud Riad

Lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams maternity hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr A Riad, MD

Role: CONTACT

amr.riad@med.asu.edu.eg

01005347179 ext. +2

Other Identifiers

ICSI

Identifier Type: -

Identifier Source: org_study_id