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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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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN95746843 |
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Date of registration:
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11/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of PDE inhibitors for endometrial growth
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Scientific title:
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PDE inhibitors and endometrial growth under clomiphene ovarian stimulation |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN95746843 |
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Study type:
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Interventional |
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Study design:
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Randomised single centre cross over study (Treatment)
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Phase:
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Phase II
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Daniel Humberto
Mendez Lozano |
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Address:
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Batallón de San Patricio 112
Real de San Agustin
66278
San Pedro Garza Garcia
Mexico |
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Telephone:
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(52) 8115553109 |
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Email:
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danielmendez@itesm.mx |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Infertile patients candidates to clomiphene ovarian stimulation
2. Female
3. 18 to 42 years old
Exclusion criteria:
1. Smoking
2. Arterial hypertension
3. Prior uterine surgery
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility. Poor endometrial growth.
Pregnancy and Childbirth
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Intervention(s)
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Patients will be randomized according to previously sealed envelopes in order to start with Cycle A or Cycle B.
1. Cycle A: patients will receive clomiphene citrate 100 mg/day from the 2nd to the 6th day of the cycle and also tadalafil 5 mg/day from the 4th day to the 10th day of the cycle.
2. Cycle B (control): patients will only receive clomiphene citrate 100 mg/day from the 2nd to the 6th day of the cycle.
All patients will be monitored until the evidence of clinical pregnancy by ultrasound.
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Primary Outcome(s)
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Endometrial growth, using ultrasound scans at day 4, 8 and 10.
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Secondary Outcome(s)
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1. Uterine artery pulsatility index
2. Uterine artery resistant index
Measured by ultrasound on Day 4, 8 and 10.
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Source(s) of Monetary Support
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Monterrey Institute of Technology and Higher Education (Tecnológico de Monterrey), CREASIS - Assisted Reproduction Center (Mexico)
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Ethics review
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Status:
Approval date:
Contact:
Institutional Ethics Committee, 27/08/2013, ref: IPDE5EC
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2015 |
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URL:
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