Timing Frozen Embryo Transfer by Following Two Different Methods

Not Applicable

Completed

• Conditions: Fertility Disorders
• Interventions: Device: Test use

• Registration Number: NCT03156374
• Lead Sponsor: SPD Development Company Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-28
• Study Start: 2017-04-30
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Primary Completion: 2019-08-28
• Study Completion: 2019-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovulation test use	Test use	Use of both ovulation tests and standardised care

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measurement of women's psychological distress	9 months	Use of validated questionnaire to assess stress level
Positive and negative experience in using ovulation tests in FET	9 months	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
FET success	9 months	Implantation rate

Trial Locations

Locations (1)

IVFAustralia - Bondi Junction; 🇦🇺 Bondi Junction, New South Wales, Australia