Debate on Progesterone Elevation on the Day of Triggering

NCT ID: NCT04253470

Last Updated: 2020-02-05

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

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Progesterone ART Female Infertility Embryo Transfer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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cleavage stage embryo

embryo which is on day 2 or 3

embryo transfer

Intervention Type OTHER

Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy

blastocyst embryo

embryo which is on day 5

embryo transfer

Intervention Type OTHER

Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy

Interventions

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embryo transfer

Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raffaella De Cesare

Role: PRINCIPAL_INVESTIGATOR

Humanitas clinical and research hospital

Locations

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Paolo Emanuele Levi Setti

Rozzano, MI, Italy

Site Status

Countries

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Italy

References

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De Cesare R, Morenghi E, Cirillo F, Ronchetti C, Canevisio V, Persico P, Baggiani A, Sandri MT, Levi-Setti PE. The Role of hCG Triggering Progesterone Levels: A Real-World Retrospective Cohort Study of More Than 8000 IVF/ICSI Cycles. Front Endocrinol (Lausanne). 2020 Sep 23;11:547684. doi: 10.3389/fendo.2020.547684. eCollection 2020.

Reference Type DERIVED
PMID: 33071968 (View on PubMed)

Other Identifiers

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2020xxxx

Identifier Type: -

Identifier Source: org_study_id

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