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

Kinetics in Time-lapse Culture of Human Preembryos

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.

Study Overview

• Status: Completed
• Conditions: Female Infertility

• Study Type: Observational
• Enrollment (Actual): 356

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Frederiksberg, Copenhagen, Denmark
      • Danish Fertility Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women suffering from infertility

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; Women treated with Menopur
Group 2; Women treated with Menopur and Bravelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Implantation rate	2 months
Ongoing pregnancy rate week 7	3 months
Live birth rate	9 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 10, 2015
• Study Completion (Actual): March 10, 2016

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 29, 2012

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: Infertility; Infertility, Female
• Other Study ID Numbers: 000063