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

Female Infertility Clinical Trial

Official title:

Kinetics in Time-lapse Culture of Human Preembryos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674894
• Other study ID #: 000063
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: August 25, 2017
• Start date: January 2013
• Est. completion date: March 10, 2016

Study information

• Verified date: August 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: March 10, 2016
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 38 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Locations

Country	Name	City	State
Denmark	Danish Fertility Clinic	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)		Week 1 after oocyte retrieval
Primary	Time for disappearance of pronuclei in transferred embryos		Week 1 after oocyte retrieval
Primary	Time for first cleavage in transferred embryos		Week 1 after oocyte retrieval
Primary	Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos		Week 1 after oocyte retrieval
Primary	Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage		Week 1 after oocyte retrieval
Secondary	Total dose of gonadotrophin used		1 month
Secondary	Gonadotrophin dose per oocyte retrieved		1 month
Secondary	Number of oocytes retrieved		1 month
Secondary	Number of fertilized and cleaved oocytes		1 month
Secondary	Number of preembryos with top quality		1 month
Secondary	Implantation rate		2 months
Secondary	Ongoing pregnancy rate week 7		3 months
Secondary	Live birth rate		9 months