Female , InfertilityPhase 4NCT02696330
Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI
A Phase 4 study testing clopidogrel and enoxaparin in people with Female , Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female , Infertility
- What is being tested?
- clopidogrel and enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Age <20 or >35 yrs old.
- Chronic medical disease.
- Single embryo transfer.
- Previous ICSI failure.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI
Read the 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
- Being tested
- clopidogrel, enoxaparin, placebo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called plavix
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
enoxaparinDrug
Also called clexane
enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
placeboDrug
starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel | Active comparator | 50 patients undergoing ICSI Receives: Drug: clopidogrel |
| enoxaparin | Active comparator | 50 patients undergoing ICSI Receives: Drug: enoxaparin |
| placebo | Placebo comparator | 50 patients undergoing ICSI Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy
number of participants with positive serum hCG indicating pregnancy
Measured: 24 hours
Secondary outcomes (1)
endometrial and subendometrial blood flow
number of participants with improved endometrial and subendometrial blood flow by 2D Doppler ultrasound
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female , InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696330
- Sponsor's protocol ID
- ICSI
- Status last verified
- Feb 2016
- First submitted
- 12 Feb 2016
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI
- ClinicalTrials.gov ID
- NCT02696330
- Acronym / sponsor ID
- ICSI
- Conditions
- Female , Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | Active comparator | Drug: clopidogrel50 patients undergoing ICSI |
| enoxaparin | Active comparator | Drug: enoxaparin50 patients undergoing ICSI |
| placebo | Placebo comparator | Drug: placebo50 patients undergoing ICSI |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Age <20 or >35 yrs old.
- Chronic medical disease.
- Single embryo transfer.
- Previous ICSI failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelAlso: plavixclopidogrel 75mg tablets with 300mg loading dose followed by 75mg oral tablets daily starting from day of hCG trigger till assessment of pregnancy by ultrasound | Drug | clopidogrel |
| enoxaparinAlso: clexaneenoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound | Drug | enoxaparin |
| placebostarch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound | Drug | placebo |
Primary outcome
clinical pregnancy
Time frame: 24 hours
number of participants with positive serum hCG indicating pregnancy
1 secondary outcome
endometrial and subendometrial blood flow
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel and enoxaparin in people with Female , Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Riad, MD (01005347179 ext. +2, amr.riad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.