|- candidate number||23504|
|- NTR Number||NTR5599|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2015|
|- Secondary IDs||80-83700-98-16505 |
|- Public Title||Intrauterine insemination for unexplained or mild male subfertility|
|- Scientific Title||Intrauterine insemination for unexplained or mild male subfertility|
|- hypothesis||We hypothesize that 6 months of expectant management does not result in decreased ongoing pregnancy rates as 6 months of treatment with IUI-OH.|
|- Healt Condition(s) or Problem(s) studied||Unexplained infertility, Intra-uterine insemination (IUI)|
|- Inclusion criteria||12 months unprotected intercourse without conception,
female age between 18 and 42 years, a regular ovulatory
cycle and at least one patent fallopian tube. The male
partner has no or a mild impairment of semen quality with a
total motile sperm count (TMSC or VCM) above 3 million.
Obtained written informed consent. A 12-month prognosis
for natural conception (calculated according to the model of
Hunault) of 30% or less, or a 12-month prognosis of more
than 30% and returning after 6 months of expectant
management without conception.|
|- Exclusion criteria||IUI-OH with sperm donation, couples with a medical contra
indication for pregnancy, couples with previous ART in the
current treatment episode|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2016|
|- planned closingdate|
|- Target number of participants||1091|
|- Interventions||Expectant management (experimental arm) vs intra uterine
insemination with ovarian hyperstimulation (control arm)|
|- Primary outcome||The primary outcome is ongoing pregnancy leading to a live birth occurring within 6 months after randomization. Live birth is defined as the birth of a live baby at 24 or more weeks of gestation.|
|- Secondary outcome||Secondary outcomes are number of incomplete/cancelled
cycles, clinical pregnancy (defined as the presence of a
gestational sac at 5-7 weeks after IUI) ongoing pregnancy,
(defined as a the presence of a positive heartbeat at 10
weeks after IUI), multiple pregnancy (defined as two or
more gestational sacs at 5-7 weeks after IUI), ongoing
multiple pregnancy (defined as the presence of two or more
heart beats at 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),
time to ongoing pregnancy, pregnancy outcomes (such as
birth weight and premature birth or pre-eclampsia), couples
preference, quality of life and financial costs.|
|- Timepoints||6 months |
|- Trial web site||www.studies-obsgyn.nl/exiui|
|- CONTACT FOR PUBLIC QUERIES||dr. F. Mol|
|- CONTACT for SCIENTIFIC QUERIES||dr. F. Mol|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||BACKGROUND
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.
THE PRIMARY 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.
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.
STUDY POPULATION Couples diagnosed with unexplained or
mild male subfertility according to the Dutch guideline and
an unfavourable prognosis for natural conception.
INTERVENTION: 6 months expectant management.
STANDARD INTERVENTION TO BE COMPARED: 6 months IUI-OH .
OUTCOME MEASURES: Ongoing pregnancies leading to a live birth conceived within 6 months after randomisation
SAMPLE SIZE: We expect a 30% live birth rate after 6
months IUI-COH. To evaluate whether 6 months expectant
management does not result in a decrease of an ongoing
pregnancy rate of 7%, we need 982 patients. (power 80%,
alpha error 0.05). Anticipating 10% lost to follow up, we
need to randomise 1,091 women.
|- Main changes (audit trail)|
|- RECORD||18-dec-2015 - 8-aug-2016|