Prevention of multiple pregnancies in couples with unexplained or mild male subfertility
| ISRCTN | ISRCTN52843371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52843371 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 15/01/2015
- 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 M.H. Mochtar
Scientific
Scientific
Academic Medical Centre
Centre for Reproductive Medicine
Amsterdam
1100 DE
Netherlands
| M.H.Mochtar@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Prevention of multiple pregnancies in couples with unexplained or mild male subfertility |
| Study acronym | INeS-study |
| Study objectives | Multiple pregnancies can be prevented without loss of pregnancy rates by treating couples with manipulated natural cycle In Vitro Fertilisation (IVF) or with IVF-eSET (Single Embryo Transfer) plus cryo-cycles instead of standard treatment with intra-uterine insemination and controlled ovarian hyperstimulation. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple pregnancies |
| Intervention | The comparisons are: 1. Six cycles of intra-uterine insemination with controlled ovarian hyperstimulation 2. Six cycles of manipulated natural cycle IVF 3. Three cycles with IVF-eSET plus cryo-cycles Performed within a time frame of 10 months |
| Intervention type | Other |
| Primary outcome measure | Birth of a healthy child. |
| Secondary outcome measures | 1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation 2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography 3. Neonatal mortality 4. Pregnancy complications: a. preterm birth less than 37 weeks b. birth weight less than 2.500 grams c. Pregnancy Induced Hypertension (PIH) d. (pre)-eclampsia, HELLP (Haemolysis, Elevated Liver enzymes, Low blood levels of Platelets) 5. Costs |
| Overall study start date | 01/07/2007 |
| Completion date | 12/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 38 Years |
| Sex | Female |
| Target number of participants | 600 |
| Key inclusion criteria | Couples are eligible if the following apply: 1. Females aged between 18 and 38 years 2. Failure to conceive within at least 12 months of unprotected intercourse 3. The couple has poor fertility prospects as calculated by the validated model of Hunault. A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months |
| Key exclusion criteria | Couples must not be entered if any of the following apply: 1. Polycystic ovary syndrome or any other anovulation 2. Post-wash total motile sperm count below 3 million 3. Double-sided tubal pathology 4. Endocrinopathological disease like: a. Cushing syndrome b. adrenal hyperplasia c. hyperprolactinaemia d. acromegaly e. imminent ovarian failure f. premature ovarian failure g. hypothalamic amenorrhoea h. hypothyroidy i. diabetes mellitus type one 5. Negative post-coitus test 6. If not willing or able to sign the consent form |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 12/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/index.cfm?sid=1 |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/01/2015 | Yes | No |
