Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847283
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-04-07
Brief Title:
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients An RCT
Sponsor:
Tam Anh TP Ho Chi Minh General Hospital
Organization:
Tam Anh TP Ho Chi Minh General Hospital
Study Overview
Official Title:
Dydrogesterone Primed Ovarian Stimulation Versus Fixed Gonadotropin Releasing Hormone Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients A Randomized Controlled Trial
Status:
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:
DPOS
Brief Summary:
One of the barriers in patients with diminished ovarian reserve DOR is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential option with a comparable success rate and reasonable cost
Progestin-primed ovarian stimulation PPOS protocol could be suggested as an alternative method of premature Luteinizing hormone LH prevention in IVF It favors segment Assisted Reproductive Technology ART cycles such as frozen embryo transfer FET oocyte donor fertility preservation and oocyte accumulation set The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation
Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone DYG Micronised Progesterone MIP and Medroxyprogesterone acetate MPA Indeed DYG seems to have some advantages including oral administration and safety which has been used in the treatment of threatened abortion Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens However data related to the PPOS protocol has not been well documented including Dydrogesteron-primed ovarian stimulation DPOS
There has not been an RCT with a large sample size and well-designed to provide more substantial evidence A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed
Progestin-primed ovarian stimulation PPOS protocol could be suggested as an alternative method of premature Luteinizing hormone LH prevention in IVF It favors segment Assisted Reproductive Technology ART cycles such as frozen embryo transfer FET oocyte donor fertility preservation and oocyte accumulation set The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation
Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone DYG Micronised Progesterone MIP and Medroxyprogesterone acetate MPA Indeed DYG seems to have some advantages including oral administration and safety which has been used in the treatment of threatened abortion Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens However data related to the PPOS protocol has not been well documented including Dydrogesteron-primed ovarian stimulation DPOS
There has not been an RCT with a large sample size and well-designed to provide more substantial evidence A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed
Detailed Description:
Screening for eligibility and randomization
This trial will be conducted at Tam Anh TP Ho Chi Minh General hospital Ho Chi Minh City Vietnam and Tam Anh General hospital Ha Noi Vietnam
Women who are potentially eligible will be provided information about the trial when IVF treatment is indicated
Patients will be provided information related to the study together with the informed consent documents Signed informed consent forms will be obtained by the investigators from all women before the enrolment
Women will be randomized 11 to either DPOS or GnRH antagonist protocol
Ovarian stimulation
The patients will be stimulated with the same protocol in all OS cycles after randomization
For DPOS arm Group I Patients will be co-administered with oral DYG Duphaston 30mgd and Human Menopausal Gonadotrophin hMG 225 IUday IUd via intramuscular injection from menstrual cycle day 2 - 4 CD2 - CD4 to the day of final oocyte maturation
For GnRH antagonist arm Group II In the fixed GnRH antagonist protocol hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 CD2 - CD4 Daily administration of GnRH antagonist Ganirelix 025 mg will be initiated on the 5th day of stimulation Treatment with hMG and GnRH antagonist will be continued daily until the day of final oocyte maturation triggering
Oocytes retrieval and cryopreservation
After 36 hours of final maturation injection all follicles greater than 12mm in diameter will be aspirated
Oocyte cryopreservation will be applied to collect at least 7 1 oocytes
Matured oocytes will be frozen by vitrification CRYOTEC Method
Oocyte thawing and ICSI
For the last ovarian stimulation cycle based on the aim to collect at least 7 1 oocytes the clinician will determine the last ovarian stimulation cycle on the day of final oocyte maturation
The frozen oocytes of the previous OS cycle will be thawed all fresh and frozen oocytes will be fertilized by ICSI
The thawing process will follow the CRYOTEC Method
ICSI will be used for the fertilization of mature oocytes
Embryo cryopreservation
Both the fresh and frozen fertilized oocytes continue to culture in the CXCM medium Irvine Scientific USA to blastocyst
Freeze-all strategy is applied in both arms then the frozen embryo will be transferred in the next cycle
Endometrium preparation and embryo transfer
Endometrial preparation with hormonal replacement therapy will be performed In the following cycle the endometrium will be prepared using oral estradiol valerate Valiera Laboratories Recalcine 6 mgday starting from the second or third day of the menstrual cycle The endometrial thickness will be monitored from day six onwards and vaginal progesterone Cyclogest Actavis 800 mgday plus dydrogesterone Duphaston 10mg at the dose of 10mg twice daily will be started when endometrial thickness reaches 8 mm or more Elective single blastocyst transfer will be performed
Embryos will be thawed on the day of embryo transfer five or six days after the start of progesterone depending on the day-5 or day-6 embryo respectively Embryos will be transferred into the uterine cavity under ultrasound guidance
Pregnancy test and ultrasound to confirm fetal viability
A pregnancy test will be performed by measuring the blood beta-hCG level 10 - 11 days after embryo transfer If the pregnancy test is positive 25mIUmL the patient is indicated to use exogenous estrogen and progesterone until at least 12 weeks of gestation
A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age
The primary endpoint is ongoing pregnancy 11 - 12 weeks of gestation after the first embryo transfer
This trial will be conducted at Tam Anh TP Ho Chi Minh General hospital Ho Chi Minh City Vietnam and Tam Anh General hospital Ha Noi Vietnam
Women who are potentially eligible will be provided information about the trial when IVF treatment is indicated
Patients will be provided information related to the study together with the informed consent documents Signed informed consent forms will be obtained by the investigators from all women before the enrolment
Women will be randomized 11 to either DPOS or GnRH antagonist protocol
Ovarian stimulation
The patients will be stimulated with the same protocol in all OS cycles after randomization
For DPOS arm Group I Patients will be co-administered with oral DYG Duphaston 30mgd and Human Menopausal Gonadotrophin hMG 225 IUday IUd via intramuscular injection from menstrual cycle day 2 - 4 CD2 - CD4 to the day of final oocyte maturation
For GnRH antagonist arm Group II In the fixed GnRH antagonist protocol hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 CD2 - CD4 Daily administration of GnRH antagonist Ganirelix 025 mg will be initiated on the 5th day of stimulation Treatment with hMG and GnRH antagonist will be continued daily until the day of final oocyte maturation triggering
Oocytes retrieval and cryopreservation
After 36 hours of final maturation injection all follicles greater than 12mm in diameter will be aspirated
Oocyte cryopreservation will be applied to collect at least 7 1 oocytes
Matured oocytes will be frozen by vitrification CRYOTEC Method
Oocyte thawing and ICSI
For the last ovarian stimulation cycle based on the aim to collect at least 7 1 oocytes the clinician will determine the last ovarian stimulation cycle on the day of final oocyte maturation
The frozen oocytes of the previous OS cycle will be thawed all fresh and frozen oocytes will be fertilized by ICSI
The thawing process will follow the CRYOTEC Method
ICSI will be used for the fertilization of mature oocytes
Embryo cryopreservation
Both the fresh and frozen fertilized oocytes continue to culture in the CXCM medium Irvine Scientific USA to blastocyst
Freeze-all strategy is applied in both arms then the frozen embryo will be transferred in the next cycle
Endometrium preparation and embryo transfer
Endometrial preparation with hormonal replacement therapy will be performed In the following cycle the endometrium will be prepared using oral estradiol valerate Valiera Laboratories Recalcine 6 mgday starting from the second or third day of the menstrual cycle The endometrial thickness will be monitored from day six onwards and vaginal progesterone Cyclogest Actavis 800 mgday plus dydrogesterone Duphaston 10mg at the dose of 10mg twice daily will be started when endometrial thickness reaches 8 mm or more Elective single blastocyst transfer will be performed
Embryos will be thawed on the day of embryo transfer five or six days after the start of progesterone depending on the day-5 or day-6 embryo respectively Embryos will be transferred into the uterine cavity under ultrasound guidance
Pregnancy test and ultrasound to confirm fetal viability
A pregnancy test will be performed by measuring the blood beta-hCG level 10 - 11 days after embryo transfer If the pregnancy test is positive 25mIUmL the patient is indicated to use exogenous estrogen and progesterone until at least 12 weeks of gestation
A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age
The primary endpoint is ongoing pregnancy 11 - 12 weeks of gestation after the first embryo transfer
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