Infertility
Conditions
Brief summary
This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.
Interventions
DRUGmenotropin
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 21-45 years * In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol * Receiving follicle stimulation with Menopur 600/1200 IU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells | 1 week after oocyte retrieval |
| Incidence of uneven blastomeres at the 2 and 4 cell stage | 1 week after oocyte retrieval |
| Incidence of bi- and multinucleation at 2 cell and 4 cell stage | 1 week after oocyte retrieval |
| Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage | 1 week after oocyte retrieval |
Secondary
| Measure | Time frame |
|---|---|
| Positive serum human Chorion Gonadotrophin (hCG) rate | 13-15 days after transfer |
| Live birth rate | 9 months |
| Implantation rate | 5 weeks after transfer |
| Clinical pregnancy rate | 7 weeks after transfer |
| Ongoing pregnancy rate | 10 weeks after transfer |
Countries
Denmark
Outcome results
None listed