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

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 August 28, 2014