GnRH antagonist administration for patients at high risk of severe Ovarian Hyperstimulation Syndrome (OHSS) down regulated GnRH agonist
| ISRCTN | ISRCTN58806684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58806684 |
| Protocol serial number | N/A |
| Sponsor | The Egyptian IVF-ET Centre (Egypt) |
| Funder | The Egyptian IVF-ET center |
- Submission date
- 14/12/2005
- Registration date
- 28/02/2006
- Last edited
- 24/08/2009
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mohamed Aboulghar
Scientific
Scientific
3, Street 161
Hadayek El Maadi
Cairo
11431
Egypt
| Phone | +20 2525 4944 |
|---|---|
| ghar@link.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Gonadotropin-Releasing Hormone (GnRH) antagonist has a direct impact on granulosa cells reducing estradiol (E2) production, thus may reduce incidence of severe OHSS |
| Ethics approval(s) | Approved by the Institutional review board, August 2005 |
| Health condition(s) or problem(s) studied | Ovarian Hyperstimulation Syndrome (OHSS) |
| Intervention | GnRH antagonist versus coasting (care as usual) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | GnRH antagonist |
| Primary outcome measure(s) |
Current information as of 24/08/09: |
| Key secondary outcome measure(s) |
Current information as of 24/08/09: |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 216 |
| Key inclusion criteria | Women undergoing in vitro fertilisation (IVF) or IntraCytoplasmic Sperm Injection (ICSI) trial down regulated with GnRH agonist and at risk of severe OHSS |
| Key exclusion criteria | 1. Women above 39 years old 2. Medical illness |
| Date of first enrolment | 30/11/2005 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Egypt
Study participating centre
3, Street 161
Cairo
11431
Egypt
11431
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? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | Yes | No |
