Study of the Cleavage of the Egg in Relation to the Stimulation Treatment
Kinetics in Time-lapse Culture of Human Preembryos
1 other identifier
observational
356
1 country
1
Brief Summary
This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2016
CompletedAugust 28, 2017
August 1, 2017
2.9 years
August 21, 2012
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
Week 1 after oocyte retrieval
Time for disappearance of pronuclei in transferred embryos
Week 1 after oocyte retrieval
Time for first cleavage in transferred embryos
Week 1 after oocyte retrieval
Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
Week 1 after oocyte retrieval
Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
Week 1 after oocyte retrieval
Secondary Outcomes (8)
Total dose of gonadotrophin used
1 month
Gonadotrophin dose per oocyte retrieved
1 month
Number of oocytes retrieved
1 month
Number of fertilized and cleaved oocytes
1 month
Number of preembryos with top quality
1 month
- +3 more secondary outcomes
Study Arms (2)
Group 1
Women treated with Menopur
Group 2
Women treated with Menopur and Bravelle
Eligibility Criteria
Women suffering from infertility
You may qualify if:
- IVF/ICSI treatment
- Regular cycles of 25-35 days
- Follicle stimulation with Bravelle and/or Menopur
- Women aged 38-35 years
- Long agonist or short antagonist treatment
- Willing and able to understand a Danish, English or German patient information form
- Willing and able to provide written Informed Consent
You may not qualify if:
- BMI more than 35
- Presence of hydrosalpinx on ultrasound
- FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
- Known allergic reactions to the planned medications
- Use of testicular sperm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Fertility Clinic
Frederiksberg, Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 29, 2012
Study Start
January 1, 2013
Primary Completion
December 10, 2015
Study Completion
March 10, 2016
Last Updated
August 28, 2017
Record last verified: 2017-08