Timing Frozen Embryo Transfer by Following Two Different Methods

SPD Development Company Limited46 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Fertility Disorders

Interventions

Test useDEVICE

Use of home ovulation test to predict ovulation

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IVFAustralia - Bondi Junction

Bondi Junction, New South Wales, Australia

Outcomes

Primary Outcomes

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

Time frame: 9 months

Secondary Outcomes

Measurement of women's psychological distress

Use of validated questionnaire to assess stress level

Time frame: 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

Time frame: 9 months

FET success

Implantation rate

Time frame: 9 months

Data from ClinicalTrials.gov

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