Hydrotubation before intrauterine insemination in unexplained infertility
| ISRCTN | ISRCTN76688903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76688903 |
| Protocol serial number | N/A |
| Sponsor | The Egyptian IVF-ET Center (Egypt) |
| Funder | The Egyptian IVF-ET Center (Egypt) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Ongoing pregnancy rate up to 20 weeks |
| Key secondary outcome measure(s) |
1. Pain |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
