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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696330
Recruitment Status : Unknown
Verified February 2016 by Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Female , Infertility Drug: clopidogrel Drug: enoxaparin Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. clinical pregnancy [ Time Frame: 24 hours ]
    number of participants with positive serum hCG indicating pregnancy


Secondary Outcome Measures :
  1. endometrial and subendometrial blood flow [ Time Frame: 24 hours ]
    number of participants with improved endometrial and subendometrial blood flow by 2D Doppler ultrasound



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696330


Contacts
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Contact: Amr A Riad, MD 01005347179 ext +2 amr.riad@med.asu.edu.eg

Locations
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Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital

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Responsible Party: Amr Ahmed Mahmoud Riad, Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02696330    
Other Study ID Numbers: ICSI
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs