Contact information
Type
Scientific
Primary contact
Prof Mohamed Aboulghar
ORCID ID
Contact details
10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt
ghar@link.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prospective randomised study for hydrotubation versus no hydrotubation before intrauterine insemination in unexplained infertility
Acronym
Study hypothesis
Hydrotubation before intrauterine insemination (IUI) may improve pregnancy rate.
Ethics approval
Ethical committee of the Egyptian IVF center approved on the 20th December 2008 (ref: 4/2009)
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infertility
Intervention
Intervention: hydrotubation was performed on the day of randomisation and IUI was performed next day
Control: identical treatment to above apart from no hydrotubation
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Ongoing pregnancy rate up to 20 weeks
Secondary outcome measures
1. Pain
2. Discomfort
Measured in the first week after hydrotubation.
Overall trial start date
01/01/2009
Overall trial end date
01/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
228
Participant exclusion criteria
1. Tubal factor
2. Male factor
3. Ovulatory factor
Recruitment start date
01/01/2009
Recruitment end date
01/11/2009
Locations
Countries of recruitment
Egypt
Trial participating centre
10 Geziret El Arab St.
Cairo
12411
Egypt
Sponsor information
Organisation
The Egyptian IVF-ET Center (Egypt)
Sponsor details
3
St 161 Hadaek El Maadi
Cairo
12411
Egypt
ivf@link.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Egyptian IVF-ET Center (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary