unexplained subfertility and mild male subfertility
Conditions
Interventions
6 months expectant management. STANDARD INTERVENTION TO BE COMPARED: 6 months
IUI-OH .
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 % Hunault model) and returning after 6 months expectant management without conception. - Obtained written informed consent.
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| * 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 | — |
Countries
Netherlands
Outcome results
None listed