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

August 25, 2017 updated by: Ferring Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

738

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Horsens, Denmark
        • Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seeking fertility treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women treated with Menopur
Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled.
Drug: menotropin
Other Names:
  • Menopur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells
Time Frame: 1 week after oocyte retrieval
1 week after oocyte retrieval
Incidence of uneven blastomeres at the 2 and 4 cell stage
Time Frame: 1 week after oocyte retrieval
1 week after oocyte retrieval
Incidence of bi- and multinucleation at 2 cell and 4 cell stage
Time Frame: 1 week after oocyte retrieval
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
Time Frame: 1 week after oocyte retrieval
1 week after oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: 9 months
9 months
Positive serum human Chorion Gonadotrophin (hCG) rate
Time Frame: 13-15 days after transfer
13-15 days after transfer
Implantation rate
Time Frame: 5 weeks after transfer
5 weeks after transfer
Clinical pregnancy rate
Time Frame: 7 weeks after transfer
7 weeks after transfer
Ongoing pregnancy rate
Time Frame: 10 weeks after transfer
10 weeks after transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 12, 2016

Study Completion (Actual)

May 12, 2016

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on menotropin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe