Contact information
Type
Scientific
Primary contact
Mr AH Balen
ORCID ID
Contact details
Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2728
adam.balen@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118096
Study information
Scientific title
Acronym
Study hypothesis
A prospective, randomised study on patients undergoing IVF or IVF/intracytoplasmic sperm injection (ICSI) receiving HCG injection in three different time scales (at the standard time, delay 24 or 48 h) when they are ready to be scheduled for the oocyte retrieval. HCG is employed to initiate maturation of oocytes and ovulation before the egg collection 36 h later. The main objective is to determine whether there is an optimal time to give HCG injection; and also to observe any differences in the number of eggs being collected, fertilisation rates, embryos quality and pregnancy rates among the three groups.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and Childbirth: In vitro fertilisation (IVF)
Intervention
Laboratory study; Case-note review; Randomised controlled trial, Random allocation to receive HCG injection at:
1. Standard time delay
2. 24 h delay
3. 48 h delay
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The main objective is to determine whether there is an optimal time to give HCG injection, and also to observe any differences in the number of eggs being collected, fertilisation rates, embryos quality and pregnancy rates among the three groups.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/07/2002
Overall trial end date
31/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients undergoing their first or second cycle of IVF or IVF/intracytoplasmic sperm injection (ICSI).
2. Age of partner 19-36 years.
3. Body mass index 20-30 kg/m2.
4. Serum follicle-stimulating hormone (FSH) concentration in normal range.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
31/07/2002
Recruitment end date
31/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics & Gynaecology
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22812907
Publication citations
-
Results
Morley L, Tang T, Yasmin E, Hamzeh R, Rutherford AJ, Balen AH, Timing of human chorionic gonadotrophin (hCG) hormone administration in IVF protocols using GnRH antagonists: a randomized controlled trial., Hum Fertil (Camb), 2012, 15, 3, 134-139, doi: 10.3109/14647273.2012.712739.