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

Completed

• Conditions: Female Infertility

• Registration Number: NCT01674894
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-29
• Study Start: 2013-01
• Primary Completion: 2015-12-10
• Study Completion: 2016-03-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 356

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Gonadotrophin dose per oocyte retrieved	1 month
Number of fertilized and cleaved oocytes	1 month
Implantation rate	2 months
Number of preembryos with top quality	1 month
Ongoing pregnancy rate week 7	3 months
Live birth rate	9 months
Number of oocytes retrieved	1 month
Total dose of gonadotrophin used	1 month

Trial Locations

Locations (1)

Danish Fertility Clinic; 🇩🇰 Frederiksberg, Copenhagen, Denmark