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

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018159
• Other study ID #: 000102
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: August 25, 2017
• Start date: January 2014
• Est. completion date: May 12, 2016

Study information

• Verified date: August 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 738
• Est. completion date: May 12, 2016
• Est. primary completion date: February 12, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• menotropin

Locations

Country	Name	City	State
Denmark	Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)	Horsens

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells		1 week after oocyte retrieval
Primary	Incidence of uneven blastomeres at the 2 and 4 cell stage		1 week after oocyte retrieval
Primary	Incidence of bi- and multinucleation at 2 cell and 4 cell stage		1 week after oocyte retrieval
Primary	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	Positive serum human Chorion Gonadotrophin (hCG) rate		13-15 days after transfer
Secondary	Implantation rate		5 weeks after transfer
Secondary	Clinical pregnancy rate		7 weeks after transfer
Secondary	Ongoing pregnancy rate		10 weeks after transfer
Secondary	Live birth rate		9 months