Infertility
Conditions
Brief summary
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose
Interventions
DRUGMenotrophin
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Decision made to prescribe Menopur® multidose according to Summary of product characteristics * The study cycle will be either * 1st controlled ovarian stimulation cycle ever, or * 2nd controlled ovarian stimulation cycle ever, or * 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)
Exclusion criteria
* Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.) * Diagnosed as poor responder, defined as either * \>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or * any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or * development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle * Ovarian hyperstimulation syndrome (OHSS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 10-11 weeks after embryo transfer | Defined as presence of at least 1 intrauterine pregnancy with a viable fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Luteinizing Hormone (LH) level | At baseline and last stimulation day (max 20 days after start of stimulation) | — |
| Mean Estradiol 2 (E2) level | At baseline and last stimulation day (max 20 days after start of stimulation) | — |
| Mean endometrial thickness | On last stimulation day (max 20 days after start of stimulation) | Measured by transvaginal ultrasound |
| Mean Follicle Stimulating Hormone (FSH) level | At baseline and last stimulation day (max 20 days after start of stimulation) | — |
| Number of oocytes retrieved | 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration | — |
| Fertilization rate | 1 day after oocyte retrieval | Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes |
| Follicular development | On last stimulation day (max 20 days after start of stimulation) | Number and size of follicles measured by transvaginal ultrasound |
Countries
South Korea
Outcome results
None listed