The influence of ultrasound contrast for fertility investigation on spontaneous pregnancy
| ISRCTN | ISRCTN20715945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20715945 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/08/2008
- Registration date
- 26/09/2008
- Last edited
- 27/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annika Strandell
Scientific
Scientific
Department of Obstetrics and Gynaecology
Kungälv Hospital
Kungälv
442 83
Sweden
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The influence of hysterosalpingo contrast sonography (HyCoSy) on spontaneous pregnancy |
| Study objectives | 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(s) | Ethics Committee of Medical Faculty, University of Gothenburg. Date of approval: 17/12/2001 (ref: S532-01) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2001 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 330 |
| Key inclusion criteria | Couples with at least 1 year of infertility who were scheduled for a consultation, including a HyCoSy. |
| Key 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) |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Obstetrics and Gynaecology
Kungälv
442 83
Sweden
442 83
Sweden
Sponsor information
University of Gothenburg (Sweden)
University/education
University/education
c/o Dr Annika Strandell
Department of Obstetrics and Gynecology
Sahlgrenska University Hospital
Göteborg
413 45
Sweden
| Website | http://www.gu.se/english |
|---|---|
"ROR" |
https://ror.org/01tm6cn81 |
Funders
Funder type
University/education
University of Gothenburg, Sahlgrenska University hospital (Sweden) (ref: LUA/ALF 7094)
No information available
Medical Society of Gothenburg (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
