Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
03/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes