Debate on Progesterone Elevation on the Day of Triggering

Female Infertility Clinical Trial

— PE  

Official title:

The Neverending Debate on Progesterone Elevation: Possible Solutions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253470
• Other study ID #: 2020xxxx
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: October 1, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• ART
• Embryo Transfer
• Female Infertility
• Infertility
• Infertility, Female
• Progesterone

Intervention

Other:
• embryo transfer
Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy

Locations

Country	Name	City	State
Italy	Paolo Emanuele Levi Setti	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of PE on CPR and LBR	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).	January 2012-December 2016
Secondary	Blastocyst embryo transfers' outcomes in PE	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.	January 2012-December 2016