A prospective randomised study of the optimal time for the administration of human chorionic gonadotropin (HCG) in women undergoing IVF in a gonadotropin releasing hormone (GnRH) antagonist cycle

ISRCTN ISRCTN36416379
DOI https://doi.org/10.1186/ISRCTN36416379
Secondary identifying numbers N0436118096
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
03/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr AH Balen
Scientific

Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Phone +44 (0)113 392 2728
Email adam.balen@leedsth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: In vitro fertilisation (IVF)
InterventionLaboratory 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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date31/07/2002
Completion date31/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment31/07/2002
Date of final enrolment31/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Obstetrics & Gynaecology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2012 Yes No