This large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH.
A multi-center, open-label, prospective cohorts study. Patients with a regular indication for COH/IUI (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. Patient's characteristics will be documented including age, weight, BMI, smoking status, cycle day 2 3 or 4 FSH /Estradiol levels, antral follicle count, and AMH. AMH and FSH/Estradiol will be determined centrally after completion of inclusion of all patients in the study. All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. Ovarian response will be documented by ultrasound only. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Cancellation criteria will be defined according to the national guidelines provided by the NVOG (7).
Study Type
OBSERVATIONAL
Enrollment
510
All patients will receive a fixed 75 IU rec follicle stimulating hormone per day subcutaneous injection stimulation protocol starting from cycle day 3, 4 or 5. The intervention done in this study is conform normal stimulation protocol and is not the target of this study.
OLVG
Amsterdam, Po 95500, Netherlands
NOT_YET_RECRUITINGIsala Klinieken
Zwolle, PO Box 10400, Netherlands
RECRUITINGCatharina Ziekenhuis
Eindhoven, PO Box 1350, Netherlands
To assess the relationship between AMH serum levels and ovarian response
(defined by the number of dominant follicles \>15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH. All follicles \> 11 mm will be documented
Time frame: one menstrual cycle, one month
To assess the relationship between age, weight, BMI, smoking, AFC, FSH/E2 on CD3 and ovarian response
(defined by the number of dominant follicles \>15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH.
Time frame: one menstrual cycle, one month
Pregnancy rate per started cycle.
From start of the menstrual cycle until a positive heartbeat registered at 12 weeks of gestation.
Time frame: three months
Multiple pregnancy rate per started cycle.
From start of the menstrual cycle until positive heartbeats registered at 12 weeks of gestation.
Time frame: three months
Miscarriage rate per started cycle.
miscarriage up to 16 weeks of gestation
Time frame: five months
Cancellation rate per stimulated cycle
Time frame: one menstrual cycle, one month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AMC
Amsterdam, PO Box 22660, Netherlands
NOT_YET_RECRUITINGVUMC
Amsterdam, PO Box 7057, Netherlands
NOT_YET_RECRUITINGUMC Utrecht
Utrecht, PO Box 85500, Netherlands
NOT_YET_RECRUITINGst Elizabeth Gasthuis
Tilburg, PO Box 90151, Netherlands
NOT_YET_RECRUITING