Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04537078
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-08-28
Brief Title:
Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
Sponsor:
El Shatby University Hospital for Obstetrics and Gynecology
Organization:
El Shatby University Hospital for Obstetrics and Gynecology
Study Overview
Official Title:
Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
Status:
COMPLETED
Status Verified Date:
2022-01
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 worldwide prevalence of primary and secondary infertility is estimated at 2 and 105 respectively among women aged 20-44 years and attempting to conceive Poor ovarian responders PORs involve 9-24 of patients undergoing in-vitro fertilization IVF proper tailoring of the ovarian stimulation protocol in order to maximize the number of oocytes collected represents a crucial step for them to eventually conceive
Recent evidence indicates that in the same menstrual cycle there are multiple follicular recruitment waves This coincides with the theory that folliculogenesis occurs in a wave-like fashion Thus within a single menstrual cycle there can theoretically be multiple opportunities for a clinician to collect oocytes as opposed to the conventional single cohort of antral follicles during the follicular phase
Utilizing this concept clinicians have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation FPS and the luteal-phase stimulation LPS protocols to increase the number of oocytes collected shorter within shorter period of time By increasing the number of the retrieved oocytes collected a better clinical can be assured since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups
which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear
Recent evidence indicates that in the same menstrual cycle there are multiple follicular recruitment waves This coincides with the theory that folliculogenesis occurs in a wave-like fashion Thus within a single menstrual cycle there can theoretically be multiple opportunities for a clinician to collect oocytes as opposed to the conventional single cohort of antral follicles during the follicular phase
Utilizing this concept clinicians have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation FPS and the luteal-phase stimulation LPS protocols to increase the number of oocytes collected shorter within shorter period of time By increasing the number of the retrieved oocytes collected a better clinical can be assured since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups
which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear
Detailed Description:
The study will be conducted on 90 infertile women indicated for ICSI with criteria of poor ovarian response defined by Bologna criteria All participants will be informed about the nature of the study and informed consent will be taken from all of them
Group 145 patients will be given the progestin primed double stimulation protocol
Group 2 45 patients will be given the flexible GnRh antagonist follicular controlled ovarian stimulations will be done in 2 cycles
Written informed consents will be obtained from all participants who accept to participate in the research protocol
Work up
1 Complete history taking and full assessment of different infertility factors
2 Hormonal investigations
FSH LH E2 Prolactin
AMH TSH
3 Basal transvaginal ultrasound
Clinical and embryological procedures
Group 1
I The follicular phase of the double stimulation protocol
1 luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week 003 mg ethinyl estradiol gestodene 0075 mg Gynera tab Bayer Pharma AG Berlin Germany
2 Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts
3 Dydrogesterone Duphaston Abbott company Illinois United states at 20 mgday will be started from the first day of the ovulation induction
4 Patient response will be monitored by
1 Transvaginal follicular scanning and the dose of the gonadotropins will be modified according to the response
2 Serum estradiol
3 Serum progesterone and LH on the day of triggering
5 GnRh agonist triggering Decapeptyl Ferring SAINT-PREX Switzerland in a dose of 2 ampules of 02 mg will be administered when leading follicle 18 mm in diameter
6 Oocyte pickup will be done 36 hours after GnRh administration with precaution of leaving the follicles measuring 11 mm or less
7 After the pick-up oocytes will be denuded The denuded oocytes are then assessed for nuclear status Mature oocytes will be used for ICSI
II The luteal phase of the double stimulation protocol
Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started the next day after the previous oocyte pickup simultaneously with Dydrogesterone Duphaston Abbott company Illinois United states at 20 mgday
The rest will be as the follicular phase
III Fertilization and embryo quality
The fertilization check which will be performed 16 to 20 hours after ICSI The resultant embryos will be scored and they will be vitrified for subsequent transfer
IV Embryo transfer
- Starting from the next menstrual cycle Day 3 patients will receive oral estradiol valerate Cyclo-Progynova white tablets Bayer Germany daily From Day 10 onwards endometrium growth will be monitored by transvaginal ultrasound When endometrial thickness 7 mm Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be initiated and Embryo transfer will be scheduled on Day 3 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage
V Luteal support - Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be continued until pregnancy testing 18 days after embryo transfer The pregnant cases will continue the luteal support till the 12 weeks of gestation
Group 2
VI The flexible GnRH antagonist protocol controlled ovarian stimulation This controlled ovarian stimulation will be done twice in two different cycles
In each cycle
1 luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week 003 mg ethinyl estradiol gestodene 0075 mg Gynera tab Bayer Pharma AG Berlin Germany
2 Controlled ovarian hyper-stimulation using antagonist protocol will be used Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts
3 GnRH antagonist Cetrotide Merck Serono Darmstadt Germany will be given daily as the biggest oocyte reaches size 14 mm
4 Patient response will be monitored by
1 Transvaginal follicular scanning and the dose of the gonadotropins will be modified according to the response
2 Serum estradiol
3 Serum progesterone on the day of triggering
5 GnRh agonist triggering Decapeptyl Ferring Saint-Prex Switzerland in a dose of 2 ampules 02 mg will be administered when leading follicle 18 mm in diameter While in the second cycle HCG triggering Choriomon IBSA Lugano Switzerland in a dose of 10000 IU will be administered when the leading follicle 18 mm in diameter
6 Oocyte pickup will be done 36 hours after GnRh administration
7 After the pick-up oocytes will be denuded The denuded oocytes are then assessed for nuclear status Mature oocytes will be used for ICSI
VII Fertilization and embryo quality
The fertilization check which will be performed 16 to 20 hours after ICSI The resultant embryos will be scored
Embryos of the first cycle will be vitrified while embryos of the second cycle will be freshly transferred unless there is excess for vitrification for subsequent trials of transfer
VIII Embryo transfer
- Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be initiated on the day of the oocyte pick up of the second cycle Embryo transfer will be scheduled on Day 3 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle
IX Luteal support Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be continued until pregnancy testing 18 days after embryo transfer The pregnant cases will continue the luteal support till the 12 weeks of gestation
Group 145 patients will be given the progestin primed double stimulation protocol
Group 2 45 patients will be given the flexible GnRh antagonist follicular controlled ovarian stimulations will be done in 2 cycles
Written informed consents will be obtained from all participants who accept to participate in the research protocol
Work up
1 Complete history taking and full assessment of different infertility factors
2 Hormonal investigations
FSH LH E2 Prolactin
AMH TSH
3 Basal transvaginal ultrasound
Clinical and embryological procedures
Group 1
I The follicular phase of the double stimulation protocol
1 luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week 003 mg ethinyl estradiol gestodene 0075 mg Gynera tab Bayer Pharma AG Berlin Germany
2 Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts
3 Dydrogesterone Duphaston Abbott company Illinois United states at 20 mgday will be started from the first day of the ovulation induction
4 Patient response will be monitored by
1 Transvaginal follicular scanning and the dose of the gonadotropins will be modified according to the response
2 Serum estradiol
3 Serum progesterone and LH on the day of triggering
5 GnRh agonist triggering Decapeptyl Ferring SAINT-PREX Switzerland in a dose of 2 ampules of 02 mg will be administered when leading follicle 18 mm in diameter
6 Oocyte pickup will be done 36 hours after GnRh administration with precaution of leaving the follicles measuring 11 mm or less
7 After the pick-up oocytes will be denuded The denuded oocytes are then assessed for nuclear status Mature oocytes will be used for ICSI
II The luteal phase of the double stimulation protocol
Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started the next day after the previous oocyte pickup simultaneously with Dydrogesterone Duphaston Abbott company Illinois United states at 20 mgday
The rest will be as the follicular phase
III Fertilization and embryo quality
The fertilization check which will be performed 16 to 20 hours after ICSI The resultant embryos will be scored and they will be vitrified for subsequent transfer
IV Embryo transfer
- Starting from the next menstrual cycle Day 3 patients will receive oral estradiol valerate Cyclo-Progynova white tablets Bayer Germany daily From Day 10 onwards endometrium growth will be monitored by transvaginal ultrasound When endometrial thickness 7 mm Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be initiated and Embryo transfer will be scheduled on Day 3 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage
V Luteal support - Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be continued until pregnancy testing 18 days after embryo transfer The pregnant cases will continue the luteal support till the 12 weeks of gestation
Group 2
VI The flexible GnRH antagonist protocol controlled ovarian stimulation This controlled ovarian stimulation will be done twice in two different cycles
In each cycle
1 luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week 003 mg ethinyl estradiol gestodene 0075 mg Gynera tab Bayer Pharma AG Berlin Germany
2 Controlled ovarian hyper-stimulation using antagonist protocol will be used Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts
3 GnRH antagonist Cetrotide Merck Serono Darmstadt Germany will be given daily as the biggest oocyte reaches size 14 mm
4 Patient response will be monitored by
1 Transvaginal follicular scanning and the dose of the gonadotropins will be modified according to the response
2 Serum estradiol
3 Serum progesterone on the day of triggering
5 GnRh agonist triggering Decapeptyl Ferring Saint-Prex Switzerland in a dose of 2 ampules 02 mg will be administered when leading follicle 18 mm in diameter While in the second cycle HCG triggering Choriomon IBSA Lugano Switzerland in a dose of 10000 IU will be administered when the leading follicle 18 mm in diameter
6 Oocyte pickup will be done 36 hours after GnRh administration
7 After the pick-up oocytes will be denuded The denuded oocytes are then assessed for nuclear status Mature oocytes will be used for ICSI
VII Fertilization and embryo quality
The fertilization check which will be performed 16 to 20 hours after ICSI The resultant embryos will be scored
Embryos of the first cycle will be vitrified while embryos of the second cycle will be freshly transferred unless there is excess for vitrification for subsequent trials of transfer
VIII Embryo transfer
- Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be initiated on the day of the oocyte pick up of the second cycle Embryo transfer will be scheduled on Day 3 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle
IX Luteal support Progesterone administration as 800 mgday vaginal suppositories per day and 100 mg ampule IM every other day will be continued until pregnancy testing 18 days after embryo transfer The pregnant cases will continue the luteal support till the 12 weeks of gestation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None