Novel approaches in in-vitro fertilisation (IVF)
| ISRCTN | ISRCTN35766970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35766970 |
| Protocol serial number | NTR587 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gonadotropin-releasing hormone (GnRH) |
| Primary outcome measure(s) |
The primary outcome parameters chosen for this study were: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Results article | Patient discomfort, risks and costs | 05/04/2008 | 27/10/2022 | Yes | No |
| Other publications | Psychological impact | 01/09/2007 | 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.
