NCT05184777

Brief Summary

In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

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

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

December 22, 2021

Last Update Submit

February 28, 2023

Conditions

Infertility, FemaleReproductive Sterility

Keywords

ELISASalivaProgesteroneOestradiolEarly follicular phaseMild follicular phaseLate follicular phase

Outcome Measures

Primary Outcomes (1)

  • To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.

    between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations

    12 months

Secondary Outcomes (2)

  • Diurnal variability of salivary progesterone and oestradiol levels

    12 months

  • Patient User Experience with saliva collection

    12 months

Study Arms (2)

Patients undergoing ovarian stimulation for IVF/ICSI

EXPERIMENTAL

90 patients undergoing ovarian stimulation for IVF/ICSI; Low, average and high responders will be included in equal proportions, in order to cover the widest range of hormonal values (30 blood and saliva samples per ovarian stimulation point will be taken for determination of progesterone and oestradiol).

Diagnostic Test: Determination of progesterone and oestradiol

Patients for embryo transfer (ET) undergoing hormonal replacement therapy

EXPERIMENTAL

30 patients for embryo transfer (ET) undergoing hormonal replacement therapy. These patients will only have a progesterone determination in their blood and saliva samples on the day of ET.

Diagnostic Test: Determination of progesterone and oestradiol

Interventions

Determination of progesterone and oestradiolDIAGNOSTIC_TEST

Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Patients for embryo transfer (ET) undergoing hormonal replacement therapyPatients undergoing ovarian stimulation for IVF/ICSI

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF/ICSI treatment
  • Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
  • Aged from18-45 years old.
  • BMI 19-30 kg/m2
  • Signed written informed consent

You may not qualify if:

  • Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46003, Spain

Location

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective unicentric study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

February 3, 2022

Primary Completion

May 17, 2022

Study Completion

February 20, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)