NCT02696330

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 12, 2016

Last Update Submit

February 26, 2016

Conditions

Female , Infertility

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy

    number of participants with positive serum hCG indicating pregnancy

    24 hours

Secondary Outcomes (1)

  • endometrial and subendometrial blood flow

    24 hours

Study Arms (3)

clopidogrel

ACTIVE COMPARATOR

50 patients undergoing ICSI

Drug: clopidogrel

enoxaparin

ACTIVE COMPARATOR

50 patients undergoing ICSI

Drug: enoxaparin

placebo

PLACEBO COMPARATOR

50 patients undergoing ICSI

Drug: placebo

Interventions

clopidogrelDRUG

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

Also known as: plavix
clopidogrel
enoxaparinDRUG

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

Also known as: clexane
enoxaparin
placeboDRUG

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

placebo

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Age \<20 or \>35 yrs old.
  • Chronic medical disease.
  • Single embryo transfer.
  • Previous ICSI failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

ClopidogrelEnoxaparin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Amr A Riad, MD

CONTACT

01005347179amr.riad@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 2, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

EG(1)