Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372119
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-12-27
Brief Title:
Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy LETSACT
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy for Endometrial Preparation in Women With Irregular Menstrual Cycles A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation The primary question it aims to answer is
Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation
Participants will undergo screening before endometrial preparation for frozen embryo transfer following which they will be randomly assigned to one of two groups LETS or AC In the LETS group investigators will prescribe letrozole 5 milligramsday for 5 days to stimulate follicular development and micronized progesterone 800 milligramsday for luteal phase support In contrast the AC group will receive oral estradiol valerate 6-12 milligramsday and micronized progesterone 800 milligramsday Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates
Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation
Participants will undergo screening before endometrial preparation for frozen embryo transfer following which they will be randomly assigned to one of two groups LETS or AC In the LETS group investigators will prescribe letrozole 5 milligramsday for 5 days to stimulate follicular development and micronized progesterone 800 milligramsday for luteal phase support In contrast the AC group will receive oral estradiol valerate 6-12 milligramsday and micronized progesterone 800 milligramsday Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates
Detailed Description:
Freeze-all and later frozen embryo transfer FET to reduce the risk of ovarian hyperstimulation syndrome OHSS is a common strategy in modern assisted reproduction technology ART Preparing the endometrium for FET in women with irregular menstrual cycles poses a challenge due to limited protocol options There are two basic endometrial preparation regimens before FET artificial cycle AC or natural cycle NC NC is often only considered if the woman has regular ovulation In women with irregular menstrual cycles the most popular conventional technique of endometrial preparation is AC The advantages of AC include its convenience meaning that the window of implantation can be determined actively and correctly and its adaptability meaning that the duration and the dose of exposure to estradiol and progesterone hormones can be flexibly scheduled On the other hand artificial exogenous estradiol levels may diminish endometrial receptivity increase the risk of thrombosis and cancer and negatively impact the babys outcomes Furthermore the absence of the corpus luteum and its products in early pregnancy may be associated with an increased risk of placentation deficiency and an increased risk of preeclampsia which is already common in this population
The current modern approach in endometrial preparation is to create the endometrial proliferative phase that mimics the NCs physiology and to attempt to produce the corpus luteum Previous studies showed that in the general population ovulation-based cycles resulted in considerably greater pregnancy rates than AC regardless of whether ovulation was natural or inducted Exogenous gonadotropins clomiphene citrate CC and aromatase inhibitors AI are the three types of ovulation-inducing agents widely utilized for women with irregular menstrual periods Gonadotropin is not patient-friendly due to the route of administration and increases the risk of OHSS CC is well-known for its antagonistic effect on estrogen receptors and its negative impact on endometrial receptivity Letrozole a preferred drug in the AI group has been explored for almost two decades to avoid the drawbacks of other methods First letrozole can stimulate mono-follicular growth and minimize the incidence of OHSS at a low cost and in a more patient-friendly manner Second letrozole decreases intraovarian and serum estrogen levels thereby upregulating endometrial estrogen receptors increasing endometrial sensitivity to estrogen increase and preventing premature progesterone action which results in increased endometrial proliferation Thirdly there was evidence that letrozole may improve endometrial receptivity by modulating the formation of αvβ3 and HOXA10 integrin leukemia inhibitory factor LIF L-selectin and pinopode formation
The findings of some previous studies showed that the letrozole-stimulated cycle was superior to AC in terms of improving clinical pregnancy rate live birth rate and lower risk of miscarriage preterm birth pre-ecclampisa and also decreasing the risk of ectopic pregnancy However there was also evidence that shows no consistent advantage of letrozole as compared to AC Notably prior research on the effectiveness of letrozole in endometrial preparation for FET was predominantly retrospective There were few randomized controlled trials RCT comparing the letrozole-stimulated cycle versus AC However these studies found similar treatment outcomes with two endometrial preparation methods The sample size was also limited N 150 and letrozole was often used in combination with hMG concurrently
This study will be undertaken at IVFMD a reproductive center of My Duc Hospital in Ho Chi Minh City Vietnam to provide evidence on how effective letrozole is compared to conventional AC
The current modern approach in endometrial preparation is to create the endometrial proliferative phase that mimics the NCs physiology and to attempt to produce the corpus luteum Previous studies showed that in the general population ovulation-based cycles resulted in considerably greater pregnancy rates than AC regardless of whether ovulation was natural or inducted Exogenous gonadotropins clomiphene citrate CC and aromatase inhibitors AI are the three types of ovulation-inducing agents widely utilized for women with irregular menstrual periods Gonadotropin is not patient-friendly due to the route of administration and increases the risk of OHSS CC is well-known for its antagonistic effect on estrogen receptors and its negative impact on endometrial receptivity Letrozole a preferred drug in the AI group has been explored for almost two decades to avoid the drawbacks of other methods First letrozole can stimulate mono-follicular growth and minimize the incidence of OHSS at a low cost and in a more patient-friendly manner Second letrozole decreases intraovarian and serum estrogen levels thereby upregulating endometrial estrogen receptors increasing endometrial sensitivity to estrogen increase and preventing premature progesterone action which results in increased endometrial proliferation Thirdly there was evidence that letrozole may improve endometrial receptivity by modulating the formation of αvβ3 and HOXA10 integrin leukemia inhibitory factor LIF L-selectin and pinopode formation
The findings of some previous studies showed that the letrozole-stimulated cycle was superior to AC in terms of improving clinical pregnancy rate live birth rate and lower risk of miscarriage preterm birth pre-ecclampisa and also decreasing the risk of ectopic pregnancy However there was also evidence that shows no consistent advantage of letrozole as compared to AC Notably prior research on the effectiveness of letrozole in endometrial preparation for FET was predominantly retrospective There were few randomized controlled trials RCT comparing the letrozole-stimulated cycle versus AC However these studies found similar treatment outcomes with two endometrial preparation methods The sample size was also limited N 150 and letrozole was often used in combination with hMG concurrently
This study will be undertaken at IVFMD a reproductive center of My Duc Hospital in Ho Chi Minh City Vietnam to provide evidence on how effective letrozole is compared to conventional AC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None