Condition category
Urological and Genital Diseases
Date applied
25/05/2009
Date assigned
03/07/2009
Last edited
03/07/2009
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

Prof Mohamed Aboulghar

ORCID ID

Contact details

10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt
ghar@link.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective randomised study for hydrotubation versus no hydrotubation before intrauterine insemination in unexplained infertility

Acronym

Study hypothesis

Hydrotubation before intrauterine insemination (IUI) may improve pregnancy rate.

Ethics approval

Ethical committee of the Egyptian IVF center approved on the 20th December 2008 (ref: 4/2009)

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infertility

Intervention

Intervention: hydrotubation was performed on the day of randomisation and IUI was performed next day
Control: identical treatment to above apart from no hydrotubation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ongoing pregnancy rate up to 20 weeks

Secondary outcome measures

1. Pain
2. Discomfort

Measured in the first week after hydrotubation.

Overall trial start date

01/01/2009

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females aged below 40 years
2. Diagnosis of unexplained infertility based on patent tubes diagnosed by hystersalpingography and/or laparoscopy
3. Regular cycles with ovulatory mid-luteal progesterone
4. Normal semen parameters of the husband according to World Health Organization (WHO) criteria
5. No previous treatment during the past 3 months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

228

Participant exclusion criteria

1. Tubal factor
2. Male factor
3. Ovulatory factor

Recruitment start date

01/01/2009

Recruitment end date

01/11/2009

Locations

Countries of recruitment

Egypt

Trial participating centre

10 Geziret El Arab St.
Cairo
12411
Egypt

Sponsor information

Organisation

The Egyptian IVF-ET Center (Egypt)

Sponsor details

3
St 161 Hadaek El Maadi
Cairo
12411
Egypt
ivf@link.net

Sponsor type

Hospital/treatment centre

Website

http://www.egyptianivfcenter.com/

Funders

Funder type

Hospital/treatment centre

Funder name

The Egyptian IVF-ET Center (Egypt)

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

Publication citations

Additional files

Editorial Notes