Infertility
Conditions
Keywords
intrauterine insemination, luteal phase, gonadotrophins
Brief summary
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
Interventions
DRUGcrinone (progesterone 8%, vaginal application)
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
Patients with an indication for IUI: * unexplained infertility * mild male factor infertility * minimal-mild endometriosis Women: * first IUI cycle ever * normal ovulatory cycles (26-32d) * age\<43,BMI≤30 * presence of at least one patent tube on hysterosalpingography and/or laparoscopy * normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy) Men: Total motile count ≥ 5 Million/ml after capacitation
Exclusion criteria
* Patients with contra-indication for pregnancy , infertility or progesterone use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical pregnancy rate per IUI cycle | by ultrasound at ± 5 to 6 weeks after IUI |
Secondary
| Measure | Time frame |
|---|---|
| live birth rate per IUI cycle | 40 weeks after IUI |
Countries
Belgium
Outcome results
None listed