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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	31/07/2002
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	31/07/2002
Date of final enrolment	31/01/2004

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 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	01/09/2012		Yes	No