Condition category
Pregnancy and Childbirth
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
15/10/2008
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

Dr Esther Heijnen

ORCID ID

Contact details

Department of Reproductive Medicine
University Medical Center Utrecht
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
esther.heijnen@organon.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR587

Study information

Scientific title

Acronym

Study hypothesis

Strategies involving shorter and milder ovarian stimulation protocols and single embryo transfer may allow for more in-vitro fertilisation (IVF) cycles in the same period of time, resulting in similar term live birth rate per treatment period despite a minor reduction in birth rate per treatment cycle.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infertility

Intervention

Patients were randomly assigned to undergo either:
1. Mild treatment (mild ovarian stimulation with gonadotropin-releasing hormone [GnRH] antagonist co-treatment combined with single embryo transfer), or
2. Standard treatment (stimulation with a GnRH agonist long-protocol and transfer of two embryos)

Intervention type

Drug

Phase

Not Specified

Drug names

Gonadotropin-releasing hormone (GnRH)

Primary outcome measures

The primary outcome parameters chosen for this study were:
1. Pregnancy within one year of treatment after randomisation leading to term (greater than 37 weeks gestation) live birth
2. Total costs per couple and child up to six weeks after expected delivery
3. Patient discomfort/distress during IVF treatment

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2002

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with an indication for IVF or IVF/intracytoplasmic sperm injection (ICSI) based on tubal, male or unexplained infertility were recruited
2. Patients less than 38 years with a normal menstrual cycle (cycle length between period 25 - 35 days) and without severe obesity or underweight (body mass index [BMI] 18 - 28 kg/m^2) were eligible for the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/02/2002

Recruitment end date

01/03/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Reproductive Medicine
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Reproductive Medicine
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17336650
2. http://www.ncbi.nlm.nih.gov/pubmed/17586832

Publication citations

  1. Heijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC, A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial., Lancet, 2007, 369, 9563, 743-749, doi: 10.1016/S0140-6736(07)60360-2.

  2. de Klerk C, Macklon NS, Heijnen EM, Eijkemans MJ, Fauser BC, Passchier J, Hunfeld JA, The psychological impact of IVF failure after two or more cycles of IVF with a mild versus standard treatment strategy., Hum. Reprod., 2007, 22, 9, 2554-2558, doi: 10.1093/humrep/dem171.

Additional files

Editorial Notes