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An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02018159
Enrollment
738
Registered
2013-12-23
Start date
2014-01-31
Completion date
2016-05-12
Last updated
2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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

Sponsors

Ferring Pharmaceuticals
Lead SponsorINDUSTRY

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

MeasureTime frame
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells1 week after oocyte retrieval
Incidence of uneven blastomeres at the 2 and 4 cell stage1 week after oocyte retrieval
Incidence of bi- and multinucleation at 2 cell and 4 cell stage1 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 stage1 week after oocyte retrieval

Secondary

MeasureTime frame
Positive serum human Chorion Gonadotrophin (hCG) rate13-15 days after transfer
Live birth rate9 months
Implantation rate5 weeks after transfer
Clinical pregnancy rate7 weeks after transfer
Ongoing pregnancy rate10 weeks after transfer

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026