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Completed

NCT Number: NCT03156374

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.

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Key information

Conditions

Fertility Disorders

Age range

24 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVFAustralia - Bondi Junction

Bondi Junction, New South Wales, NSW 2022, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test use

Device

Use of home ovulation test to predict ovulation

Primary outcomes

  1. Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit

    Time frame: 9 months

    Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit

Secondary outcomes

  1. Measurement of women's psychological distress

    Time frame: 9 months

    Use of validated questionnaire to assess stress level

  2. Positive and negative experience in using ovulation tests in FET

    Time frame: 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

  3. FET success

    Time frame: 9 months

    Implantation rate

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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