Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/07/2007
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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes