Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410170
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-25
Brief Title:
Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles
Sponsor:
Ottawa Fertility Centre
Organization:
Ottawa Fertility Centre
Study Overview
Official Title:
Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRA
Brief Summary:
To evaluate whether the measurement of urinary estrone glucuronide and luteinizing hormone LH concentrations with an at-home device is correlated with serum hormone levels within a natural cycle frozen embryo transfer protocol
The hypothesis is that home urinary monitoring can reliably detect the LH surge and serve as a trigger for timing the FET Results of this study may ultimately lead to change in clinical practice by reducing the number of clinic visits for serum monitoring offering a more convenient time and cost saving method of detection of LH surge If the proposed protocol were feasible and widely accepted by patients this would prompt the wide adoption of a less invasive but equally as effective FET protocol
The hypothesis is that home urinary monitoring can reliably detect the LH surge and serve as a trigger for timing the FET Results of this study may ultimately lead to change in clinical practice by reducing the number of clinic visits for serum monitoring offering a more convenient time and cost saving method of detection of LH surge If the proposed protocol were feasible and widely accepted by patients this would prompt the wide adoption of a less invasive but equally as effective FET protocol
Detailed Description:
A prospective multi-center cohort study evaluating the anticipated utility of the Mira device for detection of the LH surge in natural cycle frozen embryo transfer protocols All patients scheduled for undergoing natural cycle frozen embryo transfers at The Ottawa Fertility Centre Ottawa Ontario Canada and Olive Fertility Centre Vancouver British Columbia Canada with the ability to provide informed consent for participation will be eligible for inclusion Each individual patient may only be included once in the study
The objective of the proposed study is to evaluate whether the use of home urinary testing of quantitative estradiol metabolites and LH can be used to accurately predict ovulation and serve as a trigger for the gold standard of serum LH monitoring in a natural cycle protocol for frozen embryo transfer FET Its anticipated that this at home device will provide a reliable alternative to daily bloodwork thereby reducing the number of daily visits for serum monitoring and also increased satisfaction and quality of life with the implementation of their use within these cycles
Estrone glucuronide E3G and Pregnanediol-3-Glucoronide PdG are the major metabolites of estradiol E2 and progesterone that can be measured in the urine Similarly LH is another hormone that is commonly measured during natural cycle FET cycles and can also be quantified in the urine Urinary E3G LH and PdG measurement are commercially available with an FDA and CE registered home device called the Mira Fertility Tracker Mira Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G and LH has not been demonstrated in the context of natural cycle FET
Therefore the study will take place within a true natural cycle protocol whereby ovulation occurs spontaneously and is not triggered with exogenous hormones Patients meet to discuss the approach to FET with their physician prior to proceeding with treatment Patients are considered to be candidates for natural cycle protocol if they have regular menstrual cycles ranging in length between 27-35 days and no luteal phase concern ie significant luteal phase spotting or evidence of a short luteal phase
The objective of the proposed study is to evaluate whether the use of home urinary testing of quantitative estradiol metabolites and LH can be used to accurately predict ovulation and serve as a trigger for the gold standard of serum LH monitoring in a natural cycle protocol for frozen embryo transfer FET Its anticipated that this at home device will provide a reliable alternative to daily bloodwork thereby reducing the number of daily visits for serum monitoring and also increased satisfaction and quality of life with the implementation of their use within these cycles
Estrone glucuronide E3G and Pregnanediol-3-Glucoronide PdG are the major metabolites of estradiol E2 and progesterone that can be measured in the urine Similarly LH is another hormone that is commonly measured during natural cycle FET cycles and can also be quantified in the urine Urinary E3G LH and PdG measurement are commercially available with an FDA and CE registered home device called the Mira Fertility Tracker Mira Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G and LH has not been demonstrated in the context of natural cycle FET
Therefore the study will take place within a true natural cycle protocol whereby ovulation occurs spontaneously and is not triggered with exogenous hormones Patients meet to discuss the approach to FET with their physician prior to proceeding with treatment Patients are considered to be candidates for natural cycle protocol if they have regular menstrual cycles ranging in length between 27-35 days and no luteal phase concern ie significant luteal phase spotting or evidence of a short luteal phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None