Novel approaches in in-vitro fertilisation (IVF)
| ISRCTN | ISRCTN35766970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35766970 |
| Secondary identifying numbers | NTR587 |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 27/10/2022
- 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
Dr Esther Heijnen
Scientific
Scientific
Department of Reproductive Medicine
University Medical Center Utrecht
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| esther.heijnen@organon.com |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Novel approaches in in-vitro fertilisation (IVF) |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gonadotropin-releasing hormone (GnRH) |
| Primary outcome measure | 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 study start date | 01/02/2002 |
| Completion date | 01/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 400 |
| Total final enrolment | 404 |
| Key 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 |
| Key exclusion criteria | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Reproductive Medicine
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Reproductive Medicine
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/03/2007 | Yes | No | ||
| Other publications | Psychological impact | 01/09/2007 | Yes | No | |
| Results article | Patient discomfort, risks and costs | 05/04/2008 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
