NCT05493202

Brief Summary

To determine if measurement of urinary estrone glucuronide concentrations with an at-home device is correlated with superovulatory response during gonadotropin stimulated IVF cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 2, 2022

Last Update Submit

August 2, 2022

Conditions

in Vitro FertilizationHormone Testing

Keywords

in vitro fertilizationIVFhormone testing

Outcome Measures

Primary Outcomes (2)

  • Correlation of E3G with oocyte retrieval parameters

    Regression of E3G levels to total and mature number of oocytes retrieved

    Approximately 2 weeks per patient to complete data collection

  • Correlation of E3G and E2 levels throughout stimulation

    Comparison of urine and serum hormone levels

    Approximately 2 weeks per patient to complete data collection

Study Arms (1)

Study group

30 patients undergoing gonadotropin stimulation for IVF or egg freezing.

Device: Mira Fertility Tracker

Interventions

Mira Fertility TrackerDEVICE

Non-interventional: observational, documenting urine E3G levels during gonadotropin stimulation.

Study group

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales who are undergoing gonadotropin stimulation for IVF.
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from patients undergoing IVF or egg freezing at the Olive Fertility Centre.

You may qualify if:

  • Ages 21-45 AMH between 1-3.5 ng/mL (7.14-24.5 pmol/L) within 1 year of enrollment Gonadotropin stimulation with GnRH antagonist protocol Able to collect 1st morning urine

You may not qualify if:

  • Aversion to phlebotomy (as is normally required during IVF). Use of aromatase inhibitors during stimulation (which can affect serum E2 levels)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olive Fertility Centre

Vancouver, British Columbia, V5Z3X7, Canada

Location

Related Publications (1)

  • Nakhuda GS, Li N, Yang Z, Kang S. At-home urine estrone-3-glucuronide quantification predicts oocyte retrieval outcomes comparably with serum estradiol. F S Rep. 2023 Jan 28;4(1):43-48. doi: 10.1016/j.xfre.2023.01.006. eCollection 2023 Mar.

    PMID: 36959966DERIVED

Study Design

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

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 9, 2022

Study Start

February 20, 2022

Primary Completion

June 13, 2022

Study Completion

July 30, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

CA(1)