Contact information
Type
Scientific
Primary contact
Dr M.H. Mochtar
ORCID ID
Contact details
Academic Medical Centre
Centre for Reproductive Medicine
Amsterdam
1100 DE
Netherlands
-
M.H.Mochtar@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevention of multiple pregnancies in couples with unexplained or mild male subfertility
Acronym
INeS-study
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/07/2007
Overall trial end date
12/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
12/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25576320