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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT02306564 |
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Date of registration:
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01/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Cabergoline on Endometrial Vascularity During IntraCytoplasmic Sperm Injection
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Scientific title:
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Effect of Cabergoline on Subendometrial Vascularity During ICSI Cycles and Pregnancy Outcome |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02306564 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed M Kamel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lecturer of obstetrics & Gynecology |
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Name:
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Ahmed M Kamel, MD |
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Address:
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Telephone:
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00201120022332 |
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Email:
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Dr.ahmed.m.kamel@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age =18 - =40 years
2. Normal serum prolactin level.
3. Tubal factor of infertility.
4. Unexplained infertility.
5. BMI = 30 kg/m2.
6. Estradiol (E2)>3,500 pg/ml on day of ovulation trigger.
7. Patients who underwent coasting for OHSS prevention.
8. More than 20 follicles =11 mm on the day of final oocyte maturation.
Exclusion criteria:
1. Contraindication of pregnancy e.g.: Somatic and mental diseases, which are
contraindications for carrying of a pregnancy and childbirth, inborn malformations or
acquired deformations of uterus cavity which make embryo implantation or carrying of
a pregnancy impossible ,ovarian tumors.
2. Severe Male factor infertility.
3. Hyperprolactinemic patients.
4. Frozen embryo transfer cycles
5. Uterine Anomalies.
6. Uterine synechia.
7. History of Genital Tuberculosis.
8. Repeated implantation failure in ICSI.
9. On medication that is known to alter prolactin levels e.g antipsychotics, Atypical
agents and risperidone
10. Thyroid dysfunction.
11. Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and
hypothyroidism
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility
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Intervention(s)
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Drug: Cabergoline
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Primary Outcome(s)
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Pregnancy rate (chemical , clinical).
[Time Frame: 2 weeks after embryo transfer]
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Secondary Outcome(s)
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OHSS rate
[Time Frame: 4 weeks]
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Vascularization index (VI)
[Time Frame: 5 days]
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vascularization flow index (VFI)
[Time Frame: 5 days]
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Flow index (FI)
[Time Frame: 5 days]
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the resistance index (RI)
[Time Frame: 5 days]
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the peak systolic velocity (Vp).
[Time Frame: 5 days]
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Miscarriage rate
[Time Frame: 3 weeks after positive ßHCG]
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pulsatility index (PI)
[Time Frame: 5 days]
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the end-diastolic velocity (Vd).
[Time Frame: 5 days]
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Secondary ID(s)
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A14022014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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