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

Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI

Study Overview

• Status: Unknown
• Conditions: Female , Infertility
• Intervention / Treatment: Drug: clopidogrel; Drug: enoxaparin; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: clopidogrel; 50 patients undergoing ICSI	Drug: 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; Other Names: plavix
Active Comparator: enoxaparin; 50 patients undergoing ICSI	Drug: enoxaparin; enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound; Other Names: clexane
Placebo Comparator: placebo; 50 patients undergoing ICSI	Drug: placebo; starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	number of participants with positive serum hCG indicating pregnancy	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial and subendometrial blood flow	number of participants with improved endometrial and subendometrial blood flow by 2D Doppler ultrasound	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Clopidogrel; Enoxaparin
• Other Study ID Numbers: ICSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED