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ISRCTN
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ISRCTN76688903
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ClinicalTrials.gov identifier
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Public title
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Hydrotubation before intrauterine insemination in unexplained infertility
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Scientific title
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Prospective randomised study for hydrotubation versus no hydrotubation before intrauterine insemination in unexplained infertility
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Hydrotubation before intrauterine insemination (IUI) may improve pregnancy rate.
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Ethics approval
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Ethical committee of the Egyptian IVF center approved on the 20th December 2008 (ref: 4/2009)
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Study design
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Prospective randomised controlled trial
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Countries of recruitment
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Egypt
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Disease/condition/study domain
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Infertility
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Participants - inclusion criteria
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1. Females aged below 40 years
2. Diagnosis of unexplained infertility based on patent tubes diagnosed by hystersalpingography and/or laparoscopy
3. Regular cycles with ovulatory mid-luteal progesterone
4. Normal semen parameters of the husband according to World Health Organization (WHO) criteria
5. No previous treatment during the past 3 months
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Participants - exclusion criteria
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1. Tubal factor
2. Male factor
3. Ovulatory factor
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Anticipated start date
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01/01/2009
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Anticipated end date
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01/11/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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228
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Interventions
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Intervention: hydrotubation was performed on the day of randomisation and IUI was performed next day
Control: identical treatment to above apart from no hydrotubation
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Primary outcome measure(s)
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Ongoing pregnancy rate up to 20 weeks
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Secondary outcome measure(s)
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1. Pain
2. Discomfort
Measured in the first week after hydrotubation.
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Sources of funding
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The Egyptian IVF-ET Center (Egypt)
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Trial website
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Publications
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Contact name
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Prof
Mohamed
Aboulghar
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Address
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10 Geziret El Arab St.
Mohandessin
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City/town
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Cairo
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Zip/Postcode
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12411
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Country
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Egypt
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Email
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ghar@link.net
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Sponsor
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The Egyptian IVF-ET Center (Egypt)
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Address
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3, St 161 Hadaek El Maadi
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City/town
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Cairo
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Zip/Postcode
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12411
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Country
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Egypt
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Email
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ivf@link.net
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Sponsor website:
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http://www.egyptianivfcenter.com/
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Date applied
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25/05/2009
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Last edited
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03/07/2009
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Date ISRCTN assigned
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03/07/2009
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