Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates.

Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates

Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen).

The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: serum progesterone measurement

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

• Study Contact: Name: Xavier Donato; Phone Number: 04 91 80 14 31; Email: xdonato@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France, 13008
    • Hôpital Saint Joseph Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

all patients who need an embryo transfer in the center.

Description

Inclusion Criteria:

• Age ≥ 18 years
• planned embryo transfer
• signed informed consent

Exclusion Criteria:

• patients falsely included, major inclusion criteria not respected
• lack of social insurance
• refusal to participate in the research

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
serum progesterone measurement	Other: serum progesterone measurement; progesterone levels measurement on the day of the embryo transfer on all AMP cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum progesterone levels on the day of embryo transfer	µg/L	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	Post-embryo transfer βHCG levels (UI/l).	1 month after procedure

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: embryo transfer; serum progesterone; pregnancy rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: PROGESTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No