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OpenTrials
Completed

NCT Number: NCT02018159

An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos

This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)

Horsens, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 21-45 years
  • In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
  • Receiving follicle stimulation with Menopur 600/1200 IU

Treatment and study plan

menotropin

Drug

Other names: Menopur

Primary outcomes

  1. Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells

    Time frame: 1 week after oocyte retrieval

  2. Incidence of uneven blastomeres at the 2 and 4 cell stage

    Time frame: 1 week after oocyte retrieval

  3. Incidence of bi- and multinucleation at 2 cell and 4 cell stage

    Time frame: 1 week after oocyte retrieval

  4. Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage

    Time frame: 1 week after oocyte retrieval

Secondary outcomes

  1. Positive serum human Chorion Gonadotrophin (hCG) rate

    Time frame: 13-15 days after transfer

  2. Implantation rate

    Time frame: 5 weeks after transfer

  3. Clinical pregnancy rate

    Time frame: 7 weeks after transfer

  4. Ongoing pregnancy rate

    Time frame: 10 weeks after transfer

  5. Live birth rate

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2013
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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