To evaluate if the pregnancy rate, number of ongoing pregnancies and the number of live births after IUI increases as the time between the production of semen and the IUI is shortened.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate per patient couple (positive fetal cardiac activity 10
weeks after IUI).
Secondary outcome
Clinical pregnancy rate per IUI cycle (HCG> 50 IU /l at 16 days after IUI).
Ongoing pregnancy rate per IUI cycle (positive fetal cardiac activity 10 weeks
after IUI).
Percentage multiple pregnancies
Percentage biochemical pregnancies and abortions
Percentage/number of live births
Background summary
The ongoing pregnancy rate after IUI in VUmc has been in recent years about 7
to 8%. We would like to improve the ongoing pregnancy rate. Therefore a
literature study was done to see if there were differences in approach that
could lead to a better ongoing pregnancy rate. We found an article describing
the method quite different from the standard VUmc method. This different
approach resulted in much higher pregnancy outcomes (13-55%).
Study objective
To evaluate if the pregnancy rate, number of ongoing pregnancies and the
number of live births after IUI increases as the time between the production of
semen and the IUI is shortened.
Study design
Prospective randomised controlled clinical trial.
Intervention
Patients are inseminated approximately 3-4 hours after the production of semen
(Group I, current practice VUmc) or patients are inseminated approximately 75
minutes after the production of semen (Group II, intervention group).
Study burden and risks
All patients receive a standard IUI treatment. There are no risks associated
with participation in this study. Only the time interval between the production
of semen and the IUI is changed.
De Boelelaan 1117 gebouw Zuid, F16
Amsterdam 1081 HV
NL
De Boelelaan 1117 gebouw Zuid, F16
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients who start their first IUI treatment. All subsequent cycles fall within this study.
Patients who start a new IUI treatment after an ongoing pregnancy.
Both IUI performed in a natural cycle and stimulated cycles fall within this study.
Patients with well-adjusted, non-endocrine hormonal pathology fall within this study.
Exclusion criteria
Patients who have IUI with donorsemen.
Patients in which the semen was obtained in a different way than masturbation (bladder irrigation, electrical stimulation).
Patients who have less than 0.5 million progressive motile sperm left over after work-up of semen.
Patients with polycystic ovarian syndrome (PCOS).
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 | NL37363.029.11 |