Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The influence of hysterosalpingo contrast sonography (HyCoSy) on spontaneous pregnancy
Acronym
Study hypothesis
At our fertility centre, there was a clinical impression that patients who underwent a hysterosalpingo contrast sonography (HyCoSy) often attained spontaneous pregnancy. A second impression was that the conception occurred shortly after the HyCoSy. A retrospective analysis demonstrated that 50 patients out of 350 (15%) who underwent HyCoSy conceived within a 6 month period. The expected conception rate among patients who did not undergo a HyCoSy for various reasons was estimated to be 5%. Based on this background data a prospective randomised controlled study was initiated at our clinic. The aim of the study was to test whether the use of contrast sonography could enhance the chance of spontaneous clinical pregnancy in women undergoing infertility work-up.
Ethics approval
Ethics Committee of Medical Faculty, University of Gothenburg. Date of approval: 17/12/2001 (ref: S532-01)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Subfertility (both male and female)
Intervention
Participant recruitment took place at the Reproductive Unit of the Sahlgrenska University Hospital. Randomisation to the two study arms was carried out in blocks of 40, with stratification for age.
Intervention arm: Vaginal contrast sonography for tubal testing on enrolment in the study
Control arm (delayed intervention): Vaginal contrast sonography for tubal testing after 6 months from the day of enrolment in the study
The participants were followed up for 6 months to check for intrauterine pregnancy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Clinical pregnancy defined as a sonographically visible foetal sac, detected within 6 months from randomisation.
Secondary outcome measures
1. Live birth
2. Miscarriage
3. Ectopic pregnancy
Overall trial start date
01/12/2001
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Couples with at least 1 year of infertility who were scheduled for a consultation, including a HyCoSy.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Female age >=40 years
2. Severe male infertility (concentration <20 million/ml in the ejaculate or <1 million motile sperms in a swim-up preparation)
3. Severe tubal pathology and suspected anovulation (menstrual period longer than 35 days)
Recruitment start date
01/12/2001
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Obstetrics and Gynaecology
Kungälv
442 83
Sweden
Sponsor information
Organisation
University of Gothenburg (Sweden)
Sponsor details
c/o Dr Annika Strandell
Department of Obstetrics and Gynecology
Sahlgrenska University Hospital
Göteborg
413 45
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Gothenburg, Sahlgrenska University hospital (Sweden) (ref: LUA/ALF 7094)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Society of Gothenburg (Sweden)
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19164305
Publication citations
-
Results
Lindborg L, Thorburn J, Bergh C, Strandell A, Influence of HyCoSy on spontaneous pregnancy: a randomized controlled trial., Hum. Reprod., 2009, 24, 5, 1075-1079, doi: 10.1093/humrep/den485.