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Completed

NCT Number: NCT02129998

The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology

The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy.

The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development.

IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

The Fertility Clinic Skive

Skive, 7800, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation.

Exclusion criteria

-Prior participation in the study

Treatment and study plan

IVF/ICSI treatment

Other

Primary outcomes

  1. On-going pregnancy rate

    Time frame: 10th week of gestation

Secondary outcomes

  1. Implantation rate

    Time frame: 7th week of gestation

Sponsors and collaborators

Lead sponsor

Regionshospitalet Viborg, Skive

Other

Collaborators

  • BioIncept LLC
  • Ferring Pharmaceuticals

Registry information

Official study title

The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 2, 2014
Registry last updated
Oct 9, 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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