unexplained subfertility and mild male subfertility
Conditions
Interventions
A maximum of three cycles of IVF treatment versus natural conception within a
time horizon of 8 months.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -- Age at least 38 and younger than 42. - Had unprotected regular intercourse during at least 12 months without conception. - Normal regular ovulatory cycle between 26 and 34 days as confirmed by either history, basal temperature curve, ultrasound monitoring or serum progesterone - tubal patency of at least one tube as established with either hysterosalpingography, contrastsonography, or diagnostic laparoscopy, or a confirmed earlier intra-uterine pregnancy (miscarriage or ongoing) not through IVF, or a negative history of tubal damage in combination with a negative CAT result. - partners with normal or mildly impaired semen quality (TMSC * 3 million).
Exclusion criteria
Exclusion criteria: - Age 41 at the time of inclusion - Irregular cycle, defined as 34 days. - Double sided tubal occlusion - Poor semen quality (TMSC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate leading to live birth | — |
Secondary
| Measure | Time frame |
|---|---|
| - IVF outcome parameters, such as the total number of follicles, oocytes, MFII oocytes, germinal vesicles. - Poor ovarian response defined as the growth of less than 3 follicles of > 14 mm. under maximal ovarian stimulation of 225 EH FSH. - Total number of embryo*s and embryo quality. - Clinical pregnancy; defined as the presence of a gestational sac seen by transvaginal sonography 5-7 weeks after embryo tranfer - Ongoing pregnancy; defined as the presence of positive heart beat as seen by transvaginal sonography 10 weeks after embryo transfer. - Multiple pregnancy; defined as two or more gestational sacs seen by transvaginal sonography 5-7 weeks after embryo transfer - Ongoing multiple pregnancy; defined as two or more positive heart beats seen by transvaginal sonography 10 weeks after embryo transfer - 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 - Couples* preference, measured by means of a DCE (discrete choice experiment) (100 patients) - Generic quality of life measured by questionnaires (SF36 and fertiQoL) (100 patients), women in the expectant arm will be ask to keep a diary. - Financial Costs | — |
Countries
Netherlands
Outcome results
None listed