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

This study is currently recruiting participants.
Verified April 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01674894
First received: August 21, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Time for disappearance of pronuclei in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ] [ Designated as safety issue: No ]
  • Time for first cleavage in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ] [ Designated as safety issue: No ]
  • Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos [ Time Frame: Week 1 after oocyte retrieval ] [ Designated as safety issue: No ]
  • Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage [ Time Frame: Week 1 after oocyte retrieval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total dose of gonadotrophin used [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Gonadotrophin dose per oocyte retrieved [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of oocytes retrieved [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of fertilized and cleaved oocytes [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of preembryos with top quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Ongoing pregnancy rate week 7 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Live birth rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674894

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01674894     History of Changes
Other Study ID Numbers: 000063
Study First Received: August 21, 2012
Last Updated: April 8, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on April 17, 2014