Intrauterine insemination for unexplained or mild male subfertility

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29303

Enrollment

1091

Registered

2015-12-18

Start date

2016-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained subfertility, onverklaarde subfertiliteit, intrauterine insemination, intra uteriene inseminatie, IUI, expectant management, expectatief

Interventions

Expectant management (experimental arm) vs intra uterine insemination with ovarian hyperstimulation (control arm)

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactF. Mol

Centrum voor Voortplantingsgeneeskunde Q3-119 Academisch Medisch Centrum

f.mol@amsterdamumc.nl020 5663557

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)