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

Kinetics in Time-lapse Culture of Human Preembryos

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01674894

Enrollment

356

Registered

2012-08-29

Start date

2013-01-31

Completion date

2016-03-10

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

38 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame
Implantation rate	2 months
Total dose of gonadotrophin used	1 month
Live birth rate	9 months
Ongoing pregnancy rate week 7	3 months
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

Countries

Denmark

Outcome results