NCT04839627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 30, 2021

Last Update Submit

July 28, 2023

Conditions

Infertility

Keywords

serum progesteroneembryo transferpregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Serum progesterone levels on the day of embryo transfer

    µg/L

    During the procedure

Secondary Outcomes (1)

  • pregnancy rate

    1 month after procedure

Study Arms (1)

serum progesterone measurement

Other: serum progesterone measurement

Interventions

serum progesterone measurementOTHER

progesterone levels measurement on the day of the embryo transfer on all AMP cycles

serum progesterone measurement

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who need an embryo transfer in the center.

You may qualify if:

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

You may not qualify if:

  • lack of social insurance
  • refusal to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Joseph Marseille

Marseille, 13008, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 9, 2021

Study Start

June 16, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

FR(1)