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

NCT ID: NCT02129998

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

873 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Keywords

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Infertility IVF/ICSI Progesterone Preimplantation Factor (PIF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard IVF/ICSI treatment

IVF/ICSI treatment

Intervention Type OTHER

Interventions

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IVF/ICSI treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

BioIncept LLC

INDUSTRY

Sponsor Role collaborator

Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Professor, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Fertility Clinic Skive

Skive, , Denmark

Site Status

Countries

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Denmark

References

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Thomsen LH, Kesmodel US, Erb K, Bungum L, Pedersen D, Hauge B, Elbaek HO, Povlsen BB, Andersen CY, Humaidan P. The impact of luteal serum progesterone levels on live birth rates-a prospective study of 602 IVF/ICSI cycles. Hum Reprod. 2018 Aug 1;33(8):1506-1516. doi: 10.1093/humrep/dey226.

Reference Type DERIVED
PMID: 29955789 (View on PubMed)

Other Identifiers

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Progesterone/PIF_Skive

Identifier Type: -

Identifier Source: org_study_id