No registrations found.
ID
Source
Brief title
Health condition
Unexplained subfertility, onverklaarde subfertiliteit, intrauterine insemination, intra uteriene inseminatie, IUI, expectant management, expectatief
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
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.
STUDY POPULATION Couples diagnosed with unexplained or mild male subfertility according to the Dutch guideline and an unfavourable prognosis for natural onception.
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.
Study objective
We hypothesize that 6 months of expectant management does not result in decreased ongoing pregnancy rates as 6 months of treatment with IUI-OH.
Study design
6 months
Intervention
Expectant management (experimental arm) vs intra uterine insemination with ovarian hyperstimulation (control arm)
F. Mol
Amsterdam
The Netherlands
020 5663557
f.mol@amsterdamumc.nl
F. Mol
Amsterdam
The Netherlands
020 5663557
f.mol@amsterdamumc.nl
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
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL5455 |
| NTR-old | NTR5599 |
| Other | AMC : 80-83700-98-16505 |