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Timing Frozen Embryo Transfer by Following Two Different Methods

Swiss Precision Diagnostics (SPD) logo

Swiss Precision Diagnostics (SPD)

Status

Completed

Conditions

Fertility Disorders

Treatments

Device: Test use

Study type

Interventional

Funder types

Industry

Identifiers

NCT03156374
PROTOCOL-0897

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

Female

Ages

24 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Ovulation test use
Experimental group
Description:
Use of both ovulation tests and standardised care
Treatment:
Device: Test use

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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