To evaluate whether expectant management for 6 months does not lead to a decrease in ongoingpregnancy rate leading to a live birth compared to 6 months IUI-OH.HYPOTHESIS We hypothesize that 6 months of expectant management does not result in…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy, conceived within a time horizon of 6 months after
randomisation leading to live birth. Live Birth is defined as the birth of a
baby at 24 or more weeks gestation.
Secondary outcome
* IUI outcome parameters, such as the total number of follicles,
incomplete/cancelled cycles.
* Clinical pregnancy; defined as the presence of a gestational sac seen by
transvaginal sonography 5-7 weeks after IUI.
* Ongoing pregnancy; defined as the presence of positive heart beat as seen by
transvaginal sonography 10 weeks after IUI.
* Multiple pregnancy; defined as two or more gestational sacs seen by
transvaginal sonography 5-7 weeks after IUI
* Ongoing multiple pregnancy; defined as two or more positive heart beats seen
by transvaginal sonography 10 weeks after IUI
* Miscarriage; defined as the loss of a pregnancy prior to 16 weeks gestation
* Ectopic pregnancy, defined as the ectopic nidation of a pregnancy, confirmed
with sonography or laparoscopy
* Time to ongoing pregnancy
* Pregnancy outcomes such as birth weight and premature birth or pre-eclampsia
will be noted.
* Couples* preference, measured by means of a questionnaire (100 patients)
* Generic quality of life measured by questionnaires (SF36, fertiQoL and HADS),
women in the expectant arm will be ask to keep a diary.
* Financial Costs
Background summary
Of the 20,000 couples who yearly seek fertility treatment, more than 50% are
diagnosed with unexplained or
mild male factor subfertility. In The Netherlands, the first line treatment for
these women is intrauterine insemination with
ovarian hyperstimulation (IUI-OH) if the probability of a natural conception
within the following year is lower than 30% according
to the validated model of Hunault. An estimated 28,500 cycles are conducted
every year in the Netherlands, costing
approximately 20 million euros, without any evidence that IUI-OH increases live
birth rate compared to expectant management.
Besides the costs, IUI-OH bears a risk of multiple pregnancies. Women with a
multiple pregnancy have an increased risk of
premature birth, with associated neonatal mortality and morbidity.
Study objective
To evaluate whether expectant management for 6 months does not lead to a
decrease in ongoing
pregnancy rate leading to a live birth compared to 6 months IUI-OH.
HYPOTHESIS We hypothesize that 6 months of expectant management does not result
in decreased ongoing pregnancy rates
compared to 6 months of treatment with IUI-OH.
Study design
Randomized multicentre, non-inferiority trial with cost-effectiveness analysis.
Intervention
6 months expectant management. STANDARD INTERVENTION TO BE COMPARED: 6 months
IUI-OH .
Study burden and risks
As we compare strategies that are already in current practice, no additional
risks or burdens are expected from the study.
Meibergdreef 9 1105 AZ
Amsterdam 1105 AZ
NL
Meibergdreef 9 1105 AZ
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- At least 12 month unprotected regular intercourse or self insemination
without conception
- Regular ovulatory cycle
- At least one sided tubal patency, established according to local protocol
- Total motile sperm count (TMSC or VCM) above 3 million.
- An unfavourable prognosis for natural conception, defined as:
women of 18 years until 38 years with a prognosis < 30% (model of Hunault) or;
women of 38 years until 42 years or;
women of 18 years until 38 years with an initial favourable prognosis (>30 %
Hunault model) and returning after 6 months expectant management without
conception.
- Obtained written informed consent.
Exclusion criteria
- ART in the current treatment episode
- IUI-OH with sperm bank donation
- Couples with a medical contra indication for pregnancy
- Couples with sexual problems interfering with the occurrence of a natural
conception pregnancy.
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 | NL57383.018.16 |