To determine which insemination technique in AID (IUI or ICI) is more (cost) effective in terms of ongoing pregnancy leading to a live birth.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is ongoing pregnancy leading to a live birth within a time
horizon of eight months.
Secondary outcome
1. clinical pregnancy
2. miscarriage
3. multiple pregnancy
4. pregnancy complications (preterm birth, preeclampsia)
5. direct and indirect costs
Background summary
In the Netherlands, artificial insemination with donor sperm (AID) is widely
performed. To prevent transmission of sexually transmitted diseases such as
Human Immunodeficiency Virus (HIV) and Hepatitis B and C ), AID is performed
with cryopreserved donor sperm even though pregnancy rates per cycle are lower
for cryopreserved sperm than for fresh sperm
In the Netherlands different treatment strategies are performed; some clinics
perform intrauterine insemination (IUI) and others intracervical
inseminations(ICI) route. .
Recently, a systematic Cochrane review reported intrauterine insemination with
controlled ovarian stimulation (IUI-COS) to be more effective then
intracervical insemination with controlled ovarian stimulation (ICI-COS) using
donor sperm in terms of live birth rate. However, high pregnancy rates were
reported. In order to prevent mutiple pregnancies international guidelines like
the NICE and RCOG advise to perform IUI without the addition of ovarian
stimulation.
Studies on the effectiveness of IUI compared to ICI without addition of
controlled ovarian stimulation are scarce, and not based on randomised
controlled trials, but also show that IUI is more effective in terms of ongoing
pregnancy rate compared to ICI. Therefore, in 2012 we performed a retrospective
nationwide cohort study among eight sperm banks in the Netherlands on IUI and
ICI without controlled ovarian stimulation in 2009 and 2010. This study showed
no difference in ongoing pregnancy rate for IUI compared tot ICI without
controlled ovarian stimulation.
In addition, IUI is more expensive than ICI. These higher costs are generated
by the costs involved in processing the sperm , IUI costs around 650 Euro per
cycle, compared to 150 Euro per cycle for ICI.
Considering these uncertainties IUI may generate higher costs than ICI for no
increase in pregnancies.
Study objective
To determine which insemination technique in AID (IUI or ICI) is more (cost)
effective in terms of ongoing pregnancy leading to a live birth.
Study design
A randomised multicentre clinical trial paralleled with an economic analysis
alongside it.
Intervention
A maximum of six cycles IUI or ICI without the addition of ovarian stimulation
in a time frame of 8 months.
Study burden and risks
The strategies compared are already applied in current practice. No additional
risks are expected. Patients will be asked to fill in a questionnaire on side
effects. The possible benefit associated with participation is pregnancy in
both groups
Meibergdreef 9
Amsterdam 1104AZ
NL
Meibergdreef 9
Amsterdam 1104AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all the following criteria:
Indications for AID
o Couples with azoospermia
o Couples with failed TESE procedure
o Couples with a partner with a hereditary genetic defect
o Lesbian couples
o Single women
- Regular cycle
- Women with anovulation who become ovulatory after ovulation induction
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in tis study:
- Double sided tubal pathology
- women with a history of subfertility, other than male factor
- Women younger than 18 or older than 43 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47330.018.13 |