Debate on Progesterone Elevation on the Day of Triggering

Completed

• Conditions: ART; Progesterone; Female Infertility; Embryo Transfer
• Interventions: Other: embryo transfer

• Registration Number: NCT04253470
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2019-10-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cleavage stage embryo	embryo transfer	embryo which is on day 2 or 3
blastocyst embryo	embryo transfer	embryo which is on day 5

Primary Outcome Measures

Name	Time	Method
Impact of PE on CPR and LBR	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

Name	Time	Method
Blastocyst embryo transfers' outcomes in PE	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.

Trial Locations

Locations (1)

Paolo Emanuele Levi Setti; 🇮🇹 Rozzano, MI, Italy