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Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01674894
First received: August 21, 2012
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
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.

Condition
Female Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kinetics in Time-lapse Culture of Human Preembryos

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection) [ Time Frame: Week 1 after oocyte retrieval ]
  • Time for disappearance of pronuclei in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ]
  • Time for first cleavage in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ]
  • Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ]
  • Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage [ Time Frame: Week 1 after oocyte retrieval ]

Secondary Outcome Measures:
  • Total dose of gonadotrophin used [ Time Frame: 1 month ]
  • Gonadotrophin dose per oocyte retrieved [ Time Frame: 1 month ]
  • Number of oocytes retrieved [ Time Frame: 1 month ]
  • Number of fertilized and cleaved oocytes [ Time Frame: 1 month ]
  • Number of preembryos with top quality [ Time Frame: 1 month ]
  • Implantation rate [ Time Frame: 2 months ]
  • Ongoing pregnancy rate week 7 [ Time Frame: 3 months ]
  • Live birth rate [ Time Frame: 9 months ]

Enrollment: 272
Study Start Date: January 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Women treated with Menopur
Group 2
Women treated with Menopur and Bravelle

  Eligibility

Ages Eligible for Study:   38 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women suffering from infertility
Criteria

Inclusion Criteria:

  1. IVF/ICSI treatment
  2. Regular cycles of 25-35 days
  3. Follicle stimulation with Bravelle and/or Menopur
  4. Women aged 38-35 years
  5. Long agonist or short antagonist treatment
  6. Willing and able to understand a Danish, English or German patient information form
  7. Willing and able to provide written Informed Consent

Exclusion Criteria:

  1. BMI more than 35
  2. Presence of hydrosalpinx on ultrasound
  3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
  4. Known allergic reactions to the planned medications
  5. Use of testicular sperm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674894

Locations
Denmark
Danish Fertility Clinic
Frederiksberg, Copenhagen, Denmark
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01674894     History of Changes
Other Study ID Numbers: 000063
Study First Received: August 21, 2012
Last Updated: May 3, 2016

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on March 29, 2017