Contact information
Type
Scientific
Primary contact
Ms Jacoline Heller
ORCID ID
Contact details
National Centre for Adolescent and Adult Women with Congenital Abnorma
Queen Charlottes
Queen Charlottes
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 5363
k1m2erley@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0016152852
Study information
Scientific title
Acronym
Study hypothesis
How does psychological group therapy affect women with Mayer-Rokitansky-Kuster-Hauser (MKHR) syndrome?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Mayer-Rokitansky-Kuster-Hauser Syndrome
Intervention
Randomised controlled psychological group therapy trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To evaluate the effect of a psychological group therapy programme on women with MRKH
Secondary outcome measures
No secondary outcome measures
Overall trial start date
27/11/2004
Overall trial end date
16/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women affected with MRKH
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/11/2004
Recruitment end date
16/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Centre for Adolescent and Adult Women with Congenital Abnorma
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hammersmith Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support (UK) (Funding 2004/05)
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
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17584749
Publication citations
-
Results
Heller-Boersma JG, Schmidt UH, Edmonds DK, A randomized controlled trial of a cognitive-behavioural group intervention versus waiting-list control for women with uterovaginal agenesis (Mayer-Rokitansky-Küster-Hauser syndrome: MRKH)., Hum. Reprod., 2007, 22, 8, 2296-2301, doi: 10.1093/humrep/dem167.