Timing Frozen Embryo Transfer by Following Two Different Methods

NCT03156374 | Completed

• 1 other identifier: PROTOCOL-0897
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measurement of women's psychological distress

  9 months

• Positive and negative experience in using ovulation tests in FET

  9 months

• FET success

  9 months

Study Arms (1)

Ovulation test use

EXPERIMENTAL

Use of both ovulation tests and standardised care

Device: Test use

Interventions

Test use DEVICE

Use of home ovulation test to predict ovulation

Ovulation test use

Eligibility Criteria

• Age: 24 Years - 45 Years
• Gender Eligibility Details: Biological women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

IVFAustralia - Bondi Junction

Bondi Junction, New South Wales, NSW 2022, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel use of ovulation test and standard hospital monitoring, for agreement of methods

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 17, 2017
• Study Start: April 30, 2017
• Primary Completion: August 28, 2019
• Study Completion: September 30, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)