To evaluate the effect of 15 minutes of immobilisation after IUI on the pregnancy rate
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate per couple. Ongoing pregnancy rate is defined as an
intrauterine pregnancy showint a normal developing foetus with positive
heartbeat 10 weeks following IUI.
Secondary outcome
Ongoing pregnancy rate per cycle
Pregnancy rate per couple per cycle
Cumulative pregnancy rate per couple
Multiple gestation rate per ongoing pregnancy
Miscarriage rate per couple
Background summary
Intrauterine insemination (IUI) is an established treatment for couples with
unknown, mild male or cervical subfertility. It has been shown that several
aspects are related to pregnancy rates, such as patient characteristics, sperm
count, number of mature follicles, etcetera. However to date there is no
consensus on whether immobilisation or direct mobilisation after the
insemination has an effect on the pregnancy rate. Since approximately five
years, our centre has changed from immobilisation for 10 minutes to direct
mobilisation after IUI and no fall in pregnancy rate has been observed.
Recently, two studies found that immobilisation after IUI did have a positive
effect on the pregnancy rate but no clear explanation could be given for these
results.
Study objective
To evaluate the effect of 15 minutes of immobilisation after IUI on the
pregnancy rate
Study design
Prospective randomised controlled trial
Intervention
Patients will prospectively be randomised either to immediate mobilisation
following IUI (group I) or to remain in a supine position for 15 minutes
following IUI (group II).
Study burden and risks
All patients will receive the standard treatment for IUI, after the
insemination one group will stay supine for 15 minutes while the other group
will mobilise directly. There is no burden or risk associated with
participation. No extra monitoring of either group is needed.
Amstelveenseweg 601
1081 JC Amsterdam
NL
Amstelveenseweg 601
1081 JC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All couples with unexplained, cervical factor or male subfertility, with an indication for IUI.
Exclusion criteria
less than 2 million spermatozoa at time of insemination
cryo-preserved semen
semen retreived after flushing of the bladder
patients with endocrine disorders like polycystic ovary syndrome or imminent ovarian failure (basal FSH > 12 IU IU/L)
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 | NL32266.029.10 |