Comparison of Endometrial Protein Profile in Spontaneous Versus Stimulated Menstrual Cycles in Poor Responders

January 27, 2025 updated by: University Medical Centre Ljubljana

Distinct Endometrial Protein Profiles in Spontaneous and Stimulated Cycles in Women With Poor Ovarian Respons

Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ljubljana, Slovenia, 1000
        • Division of Obstetrics and Gynecology, university Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Primary infertility
  2. Poor ovarian response

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Poor responder women as per POSEIDON criteria
Comparison of endometrial proteome during the window of implantation between stimulated and spontaneous cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of endometrial proteome after the use of gonadotropins
Time Frame: From enrollment to the end of treatment (approximately 2 months).
Comparison of endometrial proteome during the window of implantation between spontaneous and stimulated cycles.
From enrollment to the end of treatment (approximately 2 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Eda Prof. Vrtačnik bokal, MD, PhD, Division of Obstetrics and Gynecology, university Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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