Hydrotubation before intrauterine insemination in unexplained infertility
| ISRCTN | ISRCTN76688903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76688903 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/05/2009
- Registration date
- 03/07/2009
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mohamed Aboulghar
Scientific
Scientific
10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt
| ghar@link.net |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective randomised study for hydrotubation versus no hydrotubation before intrauterine insemination in unexplained infertility |
| Study objectives | Hydrotubation before intrauterine insemination (IUI) may improve pregnancy rate. |
| Ethics approval(s) | Ethical committee of the Egyptian IVF center approved on the 20th December 2008 (ref: 4/2009) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Ongoing pregnancy rate up to 20 weeks |
| Secondary outcome measures | 1. Pain 2. Discomfort Measured in the first week after hydrotubation. |
| Overall study start date | 01/01/2009 |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 228 |
| Key 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 |
| Key exclusion criteria | 1. Tubal factor 2. Male factor 3. Ovulatory factor |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- Egypt
Study participating centre
10 Geziret El Arab St.
Cairo
12411
Egypt
12411
Egypt
Sponsor information
The Egyptian IVF-ET Center (Egypt)
Hospital/treatment centre
Hospital/treatment centre
3, St 161 Hadaek El Maadi
Cairo
12411
Egypt
| ivf@link.net | |
| Website | http://www.egyptianivfcenter.com/ |
"ROR" |
https://ror.org/035aahr55 |
Funders
Funder type
Hospital/treatment centre
The Egyptian IVF-ET Center (Egypt)
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 |
