NCT06804174

Brief Summary

Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Proteome

Keywords

endometrium, proteome, poor ovarian response, spontaneous cycle, stimulated cycle

Outcome Measures

Primary Outcomes (1)

  • Analysis of endometrial proteome after the use of gonadotropins

    Comparison of endometrial proteome during the window of implantation between spontaneous and stimulated cycles.

    From enrollment to the end of treatment (approximately 2 months).

Study Arms (1)

Poor responder women as per POSEIDON criteria

EXPERIMENTAL
Other: use of gonadotropins

Interventions

use of gonadotropinsOTHER

Comparison of endometrial proteome during the window of implantation between stimulated and spontaneous cycles.

Poor responder women as per POSEIDON criteria

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with poor ovarian response
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary infertility
  • Poor ovarian response

You may not qualify if:

  • Normal or high ovarian response to gonadotropin stimulation
  • Menstrual cycle disorders
  • Severe male cause of infertility
  • Preimplantation genetic testing
  • Pathological findings of the uterus (fibroids, endometrial polyps, adenomyosis) and fallopian tubes (distal occlusion of one or both fallopian tubes with hydrosalpinx).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Obstetrics and Gynecology, university Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Study Officials

  • Eda Prof. Vrtačnik bokal, MD, PhD

    Division of Obstetrics and Gynecology, University Medical Centre Ljubljana

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 3, 2025

Study Start

September 1, 2023

Primary Completion

June 30, 2024

Study Completion

September 1, 2024

Last Updated

February 3, 2025

Record last verified: 2024-10

Locations

SL(1)