An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
- Registration Number
- NCT02018159
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 738
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
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women treated with Menopur menotropin Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled.
- Primary Outcome Measures
Name Time Method 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 direct cleavage from 1 to 3 and from 2 to 5 cells 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 Outcome Measures
Name Time Method Positive serum human Chorion Gonadotrophin (hCG) rate 13-15 days after transfer Clinical pregnancy rate 7 weeks after transfer Live birth rate 9 months Implantation rate 5 weeks after transfer Ongoing pregnancy rate 10 weeks after transfer
Trial Locations
- Locations (1)
Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)
🇩🇰Horsens, Denmark