NCT02129998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
873

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3.2 years

First QC Date

May 1, 2014

Last Update Submit

October 6, 2017

Conditions

Infertility

Keywords

InfertilityIVF/ICSIProgesteronePreimplantation Factor (PIF)

Outcome Measures

Primary Outcomes (1)

  • On-going pregnancy rate

    10th week of gestation

Secondary Outcomes (1)

  • Implantation rate

    7th week of gestation

Study Arms (1)

Standard IVF/ICSI treatment

Other: IVF/ICSI treatment

Interventions

IVF/ICSI treatmentOTHER
Standard IVF/ICSI treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.

You may qualify if:

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

You may not qualify if:

  • Prior participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic Skive

Skive, 7800, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29955789DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Embryo culture media

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

DK(1)