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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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16 December 2017 |
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Main ID: |
NCT02359695 |
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Date of registration:
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05/02/2015 |
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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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Low-dose GH Supplementation Increases Clinical Pregnancy Rate
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Scientific title:
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Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation. |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02359695 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Spain
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Contacts
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Name:
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Mario Brassesco, 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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Centro de Infertilidad y Reproducción Humana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women with a history of POR, defined according to the Bologna criteria
- Absence of pregnancy in at least two previous IVF cycles
Exclusion Criteria:
- Body mass index = 30 kg/m2
- Presence of endocrinopathies
- Altered karyotype in one or both partners
- History of invasive ovarian surgery
- History of chronic, autoimmune or metabolic diseases
- Altered meiosis in testicular biopsy or altered sperm-FISH
- Drug therapy in the male partner
- Participation, within the previous 6 months, in another clinical trial with medication
Age minimum:
18 Years
Age maximum:
50 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: Growth Hormone
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Primary Outcome(s)
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Clinical pregnancy rate
[Time Frame: 7 weeks of gestation]
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Secondary Outcome(s)
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Number of obtained embryos
[Time Frame: 3 days after egg retrieval]
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Proportion of cycles with embryo transfer
[Time Frame: 3 days after egg retrieval]
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Retrieved oocytes
[Time Frame: On egg retrieval day]
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Embryo quality
[Time Frame: 3 days after embryo transfer]
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Secondary ID(s)
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2013-003123-11
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CIRH-BROHC-2013
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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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