Timing Frozen Embryo Transfer by Following Two Different Methods

Fertility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156374
• Other study ID #: PROTOCOL-0897
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2021
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Device:
• Test use
Use of home ovulation test to predict ovulation

Locations

Country	Name	City	State
Australia	IVFAustralia - Bondi Junction	Bondi Junction	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of women's psychological distress	Use of validated questionnaire to assess stress level	9 months
Secondary	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
Secondary	FET success	Implantation rate	9 months