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Clinical Trials/NCT04253470
NCT04253470CompletedNot Applicable

The Neverending Debate on Progesterone Elevation: Possible Solutions

Istituto Clinico Humanitas1 site in 1 country8,000 target enrollmentStarted: January 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8,000
Locations
1
Primary Endpoint
Impact of PE on CPR and LBR

Study Overview

Brief Summary

The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology.

This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016.

All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5)
  • Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc)

Exclusion Criteria

  • thawed embryo transfers deriving from PGTA.

Outcomes

Primary Outcomes

Impact of PE on CPR and LBR

Time Frame: January 2012-December 2016

To evaluate the impact of premature high serum P levels on the outcome of fresh embryo transfer cycles in terms of Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR).

Secondary Outcomes

  • Blastocyst embryo transfers' outcomes in PE(January 2012-December 2016)

Investigators

Sponsor
Istituto Clinico Humanitas
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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