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

Completed

• Conditions: Infertility
• Interventions: Drug: menotropin

• 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

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Study Start: 2014-01
• Primary Completion: 2016-02-12
• Study Completion: 2016-05-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

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

Exclusion Criteria

Not provided

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 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
Incidence of bi- and multinucleation at 2 cell 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