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 |
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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
Scientific
Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)113 392 2728 |
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adam.balen@leedsth.nhs.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/09/2012 | Yes | No |