Timing Frozen Embryo Transfer by Following Two Different Methods

Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods

This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders
• Intervention / Treatment: Device: Test use

Detailed Description

The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.

The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.

A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bondi Junction, New South Wales, Australia, NSW 2022
      • IVFAustralia - Bondi Junction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 24 to 45 years of age
• Undergoing no more than 5frozen embryo transfer
• Average cycle length between 26 and 35 days
• Willing to provide written informed consent to participate in the study and comply with all study procedures

Exclusion Criteria:

• More than five IVF frozen embryo cycle
• Undergoing FET following cancer treatment
• Self-reported drug or alcohol dependency
• Self-reported history of depression, anxiety and panic attacks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ovulation test use; Use of both ovulation tests and standardised care	Device: Test use; Use of home ovulation test to predict ovulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit	Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of women's psychological distress	Use of validated questionnaire to assess stress level	9 months
Positive and negative experience in using ovulation tests in FET	Qualitative assessment of women's FET treatment experience when using ADOT compared to standard clinical procedures during the study via a semi-structured interview following embryo transfer	9 months
FET success	Implantation rate	9 months

Collaborators and Investigators

• Sponsor: SPD Development Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-0897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No