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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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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15 November 2021 |
Main ID: |
NCT02195947 |
Date of registration:
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18/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Antagonist Protocol in Poor Responders
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Scientific title:
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Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial |
Date of first enrolment:
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July 2014 |
Target sample size:
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141 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02195947 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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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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Yomna A Bayoumi, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- females fulfilling the criteria of the ESHRE consensus 2011:
- at least two of the following three features must be present:
- dvanced maternal age (=40 years) or any other risk factor for POR
- previous POR (=3 oocytes with a conventional stimulation protocol)
- an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).
Exclusion Criteria:
- women who suffer from any other cause of infertility other than poor ovarian reserve
- refusal of the patient to consent for using her data in the study.
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Infertility Due to Diminished Ovarian Reserve
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Intervention(s)
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Drug: Growth Hormone
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Primary Outcome(s)
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Live birth rate
[Time Frame: Up to 9 months]
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Secondary Outcome(s)
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Clinical pregnancy rate
[Time Frame: Up to 5 weeks]
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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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