search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Intrauterine insemination for unexplained or mild male subfertility


- candidate number23504
- NTR NumberNTR5599
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2015
- Secondary IDs80-83700-98-16505 
- Public TitleIntrauterine insemination for unexplained or mild male subfertility
- Scientific TitleIntrauterine insemination for unexplained or mild male subfertility
- ACRONYMexIUI
- hypothesisWe 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) studiedUnexplained infertility, Intra-uterine insemination (IUI)
- Inclusion criteria12 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 criteriaIUI-OH with sperm donation, couples with a medical contra indication for pregnancy, couples with previous ART in the current treatment episode
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate
- Target number of participants1091
- InterventionsExpectant management (experimental arm) vs intra uterine insemination with ovarian hyperstimulation (control arm)
- Primary outcomeThe 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 outcomeSecondary 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.
- Timepoints6 months
- Trial web sitewww.studies-obsgyn.nl/exiui
- status[default]
- CONTACT FOR PUBLIC QUERIESdr. F. Mol
- CONTACT for SCIENTIFIC QUERIESdr. F. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBACKGROUND 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 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)
- RECORD18-dec-2015 - 8-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl