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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | GnRH antagonist |
| Primary outcome measure | Current information as of 24/08/09: High quality embryos Initial information at time of registration: OHSS |
| Secondary outcome measures | Current information as of 24/08/09: 1. Days of intervention 2. Number of oocytes 3. Pregnancy rate 4. Number of cryopreserved embryos 5. Incidence of severe OHSS Initial information at time of registration: Pregnancy rate |
| Overall study start date | 30/11/2005 |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 216 (108 - antagonist; 108 - coasting) |
| 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
Sponsor information
The Egyptian IVF-ET Centre (Egypt)
Hospital/treatment centre
Hospital/treatment centre
3, Street 161
Hadayek El Maadi
Cairo
11431
Egypt
| Phone | +20 (0)2 5254944 |
|---|---|
| ghar@link.net | |
"ROR" |
https://ror.org/035aahr55 |
Funders
Funder type
Hospital/treatment centre
The Egyptian IVF-ET center
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | Yes | No |
