Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239376
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-12-18
Brief Title:
Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
The Effectiveness of the Two Different Endometrial Preparation Regimes for Frozen Embryo Transfer in Patients With Adenomyosis
Status:
RECRUITING
Status Verified Date:
2024-02
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:
FET-ADE
Brief Summary:
This randomized clinical trial aims to assess the comparative effectiveness of two distinct endometrial preparation protocols for frozen embryo transfer FET among women with adenomyosis undergoing IVFICSI Specifically it seeks to address the following key questions
1 Does the protocol involving the combination of GnRH agonist and letrozole for down regulation with exogenous steroids GnRHaAI - AC result in a higher live birth rate compared to the use of exogenous steroids alone AC in women with adenomyosis undergoing frozen embryo transfer
2 What are the common side effects of the GnRHaAI - AC regimen
Eligible participants will undergo screening before endometrial preparation for FET following which they will be randomly assigned to one of two groups GnRHaAI - AC or AC In the GnRHaAI - AC group participants will be pre-treated with GnRH agonist and letrozole two months before endometrial preparation After this period participants will return for endometrial preparation and any side effects resulting from the down regulation will be evaluated In contrast the AC group will receive standard treatment
1 Does the protocol involving the combination of GnRH agonist and letrozole for down regulation with exogenous steroids GnRHaAI - AC result in a higher live birth rate compared to the use of exogenous steroids alone AC in women with adenomyosis undergoing frozen embryo transfer
2 What are the common side effects of the GnRHaAI - AC regimen
Eligible participants will undergo screening before endometrial preparation for FET following which they will be randomly assigned to one of two groups GnRHaAI - AC or AC In the GnRHaAI - AC group participants will be pre-treated with GnRH agonist and letrozole two months before endometrial preparation After this period participants will return for endometrial preparation and any side effects resulting from the down regulation will be evaluated In contrast the AC group will receive standard treatment
Detailed Description:
Adenomyosis is a benign gynecological disease in which the endometrial stroma invades the uterine myometrium Adenomyosis affects approximately 10 of women of reproductive age There are several hypothetical mechanisms in adenomyosis-associated infertility including dysregulations of the myometrial architecture and function chronic inflammation presence of local oxygen and altered endometrial function which can cause implantation failure The abnormal presence of endometrial tissue composed of glands and stroma impacts uterine smooth muscles regular contractile function and peristalsis resulting in menometrorrhagia infertility and adverse obstetric consequences There is currently no consensus on the optimal protocol for endometrial preparation in this population and a lack of data on this issue Current protocols include routine protocols with or without the pre-treatment of GnRH agonist However it is still controversial whether GnRH agonist down-regulation can help patients with adenomyosis have better reproductive outcomes To our knowledge there have not been any randomized controlled trials to investigate the effectiveness of the protocols used for endometrial preparation in women with adenomyosis undergoing frozen embryo transfer
This will be a superiority-designed randomized clinical trial
This trial will be conducted at My Duc Hospital Ho Chi Minh City Vietnam Potentially eligible women will be provided information about the trial as long as their stimulation cycles are initiated
Screening for eligibility will be performed by treating physicians on days 2nd - 4th of the menstrual cycle in the subsequent frozen embryo transfer cycles Patients will be provided a copy of the informed consent documents Written informed consent will be obtained from all women by the investigator before enrollment
Women will be randomized 11 to either AC artificial cycle or GnRHaAI - AC Down-Regulation with GnRH agonist and Letrozole combined with artificial cycle protocols using block randomization with a variable block size of 4 6 using HOPE Epi with a computer-generated random list
Artificial cycle AC the endometrium will be prepared using oral estradiol valerate Valiera Abbott 6 mgday starting from the second or fourth day of the menstrual cycle 5 The endometrial thickness will be monitored from the tenth day of estradiol-priming onwards and vaginal progesterone Cyclogest Actavis 400 mg twice times a day will be initiated when endometrial thickness reaches 7 mm or more and received oestradiol valerate for at least nine days
Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages Hormonal support will consist of oral estradiol valerate 4 mgday and vaginal progesterone Cyclogest Actavis 400 mg twice times a day until the 7th week of gestation Subsequently progesterone alone Cyclogest Actavis at 400 mg twice times a day will be continued for luteal phase support until the 12th week of gestation
- GnRH agonist Letrozole - Artificial cycle protocol GnRHaAI - AC
Pre-treatment with GnRH agonist GnRHa Triptorelin - Diphereline Ipsen France will be injected at a dose of 375 mg on days 2nd - 4th of menstruation In addition to GnRHa administration duration the patients will be indicated letrozole 25 mg daily Femara Novartis Switzerland to prevent the estradiol flare-up effect from the day of GnRH agonist injection Repeat the same regimen for the second time 28 days after the first injection of GnRH agonist
After 55 days of Down Regulation with GnRH agonist before starting the artificial cycle protocol for endometrial preparation estradiol serum level will be tested before endometrial preparation
Endometrial preparation with AC protocol will be started 28 days after the second injection of GnRH agonist as described previously
Frozen embryo transfer
A maximum of 2 cleavage-stage embryos or 1 blastocyst will be thawed on the day of embryo transfer three or five days after the start of progesterone Two hours after thawing surviving embryos will be transferred into the uterus under ultrasound guidance using a soft uterine catheter Gynétics Belgium
- Future babies health evaluation and cost-effectiveness analysis will also be performed separately
This will be a superiority-designed randomized clinical trial
This trial will be conducted at My Duc Hospital Ho Chi Minh City Vietnam Potentially eligible women will be provided information about the trial as long as their stimulation cycles are initiated
Screening for eligibility will be performed by treating physicians on days 2nd - 4th of the menstrual cycle in the subsequent frozen embryo transfer cycles Patients will be provided a copy of the informed consent documents Written informed consent will be obtained from all women by the investigator before enrollment
Women will be randomized 11 to either AC artificial cycle or GnRHaAI - AC Down-Regulation with GnRH agonist and Letrozole combined with artificial cycle protocols using block randomization with a variable block size of 4 6 using HOPE Epi with a computer-generated random list
Artificial cycle AC the endometrium will be prepared using oral estradiol valerate Valiera Abbott 6 mgday starting from the second or fourth day of the menstrual cycle 5 The endometrial thickness will be monitored from the tenth day of estradiol-priming onwards and vaginal progesterone Cyclogest Actavis 400 mg twice times a day will be initiated when endometrial thickness reaches 7 mm or more and received oestradiol valerate for at least nine days
Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages Hormonal support will consist of oral estradiol valerate 4 mgday and vaginal progesterone Cyclogest Actavis 400 mg twice times a day until the 7th week of gestation Subsequently progesterone alone Cyclogest Actavis at 400 mg twice times a day will be continued for luteal phase support until the 12th week of gestation
- GnRH agonist Letrozole - Artificial cycle protocol GnRHaAI - AC
Pre-treatment with GnRH agonist GnRHa Triptorelin - Diphereline Ipsen France will be injected at a dose of 375 mg on days 2nd - 4th of menstruation In addition to GnRHa administration duration the patients will be indicated letrozole 25 mg daily Femara Novartis Switzerland to prevent the estradiol flare-up effect from the day of GnRH agonist injection Repeat the same regimen for the second time 28 days after the first injection of GnRH agonist
After 55 days of Down Regulation with GnRH agonist before starting the artificial cycle protocol for endometrial preparation estradiol serum level will be tested before endometrial preparation
Endometrial preparation with AC protocol will be started 28 days after the second injection of GnRH agonist as described previously
Frozen embryo transfer
A maximum of 2 cleavage-stage embryos or 1 blastocyst will be thawed on the day of embryo transfer three or five days after the start of progesterone Two hours after thawing surviving embryos will be transferred into the uterus under ultrasound guidance using a soft uterine catheter Gynétics Belgium
- Future babies health evaluation and cost-effectiveness analysis will also be performed separately
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