Timing Frozen Embryo Transfer by Following Two Different Methods

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fertility Disorders

Intervention / Treatment
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* Device: Test use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ovulation test use<br>Use of both ovulation tests and standardised care | Device: Test use<br>* Use of home ovulation test to predict ovulation<br>|

What is the study measuring?
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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 |