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NCT02129998 Clinical Trial

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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02129998
Other study ID # Progesterone/PIF_Skive
Secondary ID
Status Completed
Phase N/A
First received May 1, 2014
Last updated October 6, 2017
Start date May 2014
Est. completion date October 2017

Study information
Verified date October 2017
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 873
Est. completion date October 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• IVF/ICSI treatment

Locations
Country Name City State
Denmark The Fertility Clinic Skive Skive

Sponsors (3)
Lead Sponsor Collaborator
Regionshospitalet Viborg, Skive BioIncept LLC, Ferring Pharmaceuticals

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary On-going pregnancy rate 10th week of gestation
Secondary Implantation rate 7th week of gestation
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