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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02129998
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : October 9, 2017
Ferring Pharmaceuticals
BioIncept LLC
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

Brief Summary:

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.

Condition or disease Intervention/treatment
Infertility Other: IVF/ICSI treatment

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Study Type : Observational
Actual Enrollment : 873 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
Actual Study Start Date : May 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
Standard IVF/ICSI treatment Other: IVF/ICSI treatment

Primary Outcome Measures :
  1. On-going pregnancy rate [ Time Frame: 10th week of gestation ]

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 7th week of gestation ]

Biospecimen Retention:   Samples Without DNA
Serum, Embryo culture media

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02129998

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The Fertility Clinic Skive
Skive, Denmark, 7800
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
Ferring Pharmaceuticals
BioIncept LLC

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter Humaidan, Professor, DMSc, Regionshospitalet Viborg, Skive Identifier: NCT02129998     History of Changes
Other Study ID Numbers: Progesterone/PIF_Skive
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Peter Humaidan, Regionshospitalet Viborg, Skive:
Preimplantation Factor (PIF)

Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs