Condition category
Pregnancy and Childbirth
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
15/01/2015
Prospective/Retrospective
Prospectively 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 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 measures

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

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

http://www.amc.uva.nl/index.cfm?sid=1

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25576320

Publication citations

Additional files

Editorial Notes