Condition category
Pregnancy and Childbirth
Date applied
15/08/2008
Date assigned
26/09/2008
Last edited
27/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Annika Strandell

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Kungälv Hospital
Kungälv
442 83
Sweden

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 measures

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

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

http://www.gu.se/english

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19164305

Publication citations

  1. 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.

Additional files

Editorial Notes