Debate on Progesterone Elevation on the Day of Triggering

NCT04253470 | Completed

• 1 other identifier: 2020xxxx
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Progesterone; ART; Female Infertility; Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blastocyst embryo transfers' outcomes in PE

  January 2012-December 2016

Study Arms (2)

cleavage stage embryo

embryo which is on day 2 or 3

Other: embryo transfer

blastocyst embryo

embryo which is on day 5

Other: embryo transfer

Interventions

embryo transfer OTHER

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

blastocyst embryo; cleavage stage embryo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• thawed embryo transfers deriving from PGTA.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Paolo Emanuele Levi Setti

Rozzano, MI, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 33071968 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Raffaella De Cesare

  Humanitas clinical and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: January 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: October 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)