Contact information
Type
Scientific
Primary contact
Prof Mohamed Aboulghar
ORCID ID
Contact details
3
Street 161
Hadayek El Maadi
Cairo
11431
Egypt
+20 2525 4944
ghar@link.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Approved by the Institutional review board, August 2005
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Ovarian Hyperstimulation Syndrome (OHSS)
Intervention
GnRH antagonist versus coasting (care as usual)
Intervention type
Drug
Phase
Not Specified
Drug names
GnRH antagonist
Primary outcome measures
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 trial start date
30/11/2005
Overall trial end date
01/06/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
216 (108 - antagonist; 108 - coasting)
Participant exclusion criteria
1. Women above 39 years old
2. Medical illness
Recruitment start date
30/11/2005
Recruitment end date
01/06/2006
Locations
Countries of recruitment
Egypt
Trial participating centre
3, Street 161
Cairo
11431
Egypt
Sponsor information
Organisation
The Egyptian IVF-ET Centre (Egypt)
Sponsor details
3
Street 161
Hadayek El Maadi
Cairo
11431
Egypt
+20 (0)2 5254944
ghar@link.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Egyptian IVF-ET center
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17854523
Publication citations
-
Results
Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI, A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS., Reprod. Biomed. Online, 2007, 15, 3, 271-279.