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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: |
NCT03358199 |
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Date of registration:
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27/11/2017 |
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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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LOD Before IVF/ICSI in PCOS Patients With High AMH
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Scientific title:
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Laparoscopic Ovarian Drilling Before IVF/ICSI in Polycystic Ovarian Syndrome Patients With High Antimullarian Hormone |
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Date of first enrolment:
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March 22, 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03358199 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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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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Maher Shams, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Waleed El-refaie, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mohamed S Abdelhafez, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Alaa Wageh, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PCOS women subjected to COS through fixed gonadotropin releasing hormone (GnRH)
antagonist protocol with final triggering of oocyte maturation by GnRH agonist (GnRHa)
- Elevated serum AMH level (= 7 ng/ml)
Exclusion Criteria:
- Age < 18 years or > 35 years
- Body mass index (BMI) < 19 kg/m2 or > 35 kg/m2
- Use of cabergoline therapy or coasting to minimize the risk of OHSS
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility
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Polycystic Ovarian Syndrome
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Intervention(s)
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Procedure: LOD
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Primary Outcome(s)
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Number of oocytes retrieved
[Time Frame: 36-38 hours after triggering of oocyte maturation]
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Oocyte maturity rate
[Time Frame: Within one hour after oocyte retrieval]
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Fertilization rate
[Time Frame: 20-24 hours after injection (or insemination)]
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Secondary Outcome(s)
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Implantation rate
[Time Frame: 6 weeks after embryo transfer]
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Clinical pregnancy rate
[Time Frame: 6 weeks after embryo transfer]
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Incidence of early OHSS
[Time Frame: Within 9 days of final triggering of oocyte maturation]
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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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