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Debate on Progesterone Elevation on the Day of Triggering (PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253470
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.


Condition or disease Intervention/treatment
Progesterone ART Female Infertility Embryo Transfer Other: embryo transfer

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Study Type : Observational
Actual Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Neverending Debate on Progesterone Elevation: Possible Solutions
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : October 1, 2019

Group/Cohort Intervention/treatment
cleavage stage embryo
embryo which is on day 2 or 3
Other: embryo transfer
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
Other: embryo transfer
Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Blastocyst embryo transfers' outcomes in PE [ Time Frame: January 2012-December 2016 ]
    Furthermore, the present study retrospectively investigates whether the transfer of blastocysts on day 5 post-fertilization (D5-ET) may improve the CPR and the LBR in patients with P rise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5), and all thawed embryo transfer, except from the ones deriving from PGTA, performed from January 2012 to December 2016 in Humanitas Fertility Center were included.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253470


Locations
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Italy
Paolo Emanuele Levi Setti
Rozzano, MI, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Raffaella De Cesare Humanitas clinical and research hospital
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04253470    
Other Study ID Numbers: 2020xxxx
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female