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OpenTrials
Completed

NCT Number: NCT01674894

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

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

38 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Danish Fertility Clinic

Frederiksberg, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IVF/ICSI treatment
  • Regular cycles of 25-35 days
  • Follicle stimulation with Bravelle and/or Menopur
  • Women aged 38-35 years
  • Long agonist or short antagonist treatment
  • Willing and able to understand a Danish, English or German patient information form
  • Willing and able to provide written Informed Consent

Exclusion criteria

  • BMI more than 35
  • Presence of hydrosalpinx on ultrasound
  • FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
  • Known allergic reactions to the planned medications
  • Use of testicular sperm

Treatment and study plan

Primary outcomes

  1. Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)

    Time frame: Week 1 after oocyte retrieval

  2. Time for disappearance of pronuclei in transferred embryos

    Time frame: Week 1 after oocyte retrieval

  3. Time for first cleavage in transferred embryos

    Time frame: Week 1 after oocyte retrieval

  4. Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos

    Time frame: Week 1 after oocyte retrieval

  5. Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage

    Time frame: Week 1 after oocyte retrieval

Secondary outcomes

  1. Total dose of gonadotrophin used

    Time frame: 1 month

  2. Gonadotrophin dose per oocyte retrieved

    Time frame: 1 month

  3. Number of oocytes retrieved

    Time frame: 1 month

  4. Number of fertilized and cleaved oocytes

    Time frame: 1 month

  5. Number of preembryos with top quality

    Time frame: 1 month

  6. Implantation rate

    Time frame: 2 months

  7. Ongoing pregnancy rate week 7

    Time frame: 3 months

  8. Live birth rate

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Kinetics in Time-lapse Culture of Human Preembryos

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 29, 2012
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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