Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199960
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2021-02-09
Brief Title:
Dual Ovarian Stimulation Duostim and Shanghai Protocols in Poor Ovarian Responders
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Comparison of Two Types of Dual Ovarian Stimulation Duostim Versus Shanghai Protocols in Patients With Poor Ovarian Reserve A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-01
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:
A combination of follicular phase stimulation and luteal phase stimulation in the same cycle can be a valuable choice in poor responder patients with reduced ovarian reserve in order to achieve extreme the number of oocytes in a single menstrual cycle In the present study the results of two different Double stimulation cycles including shanghai protocol and Duostim protocol in patients with reduced ovarian reserve compared with each other to help select a more appropriate treatment for this group of patients The number of retrieved oocytes and the number of obtained embryos and clinical pregnancy from each protocol will be compared as the primary and secondary outcome
Detailed Description:
The proposal of this randomized clinical trial study is a comparison of two different type of double stimulation protocols in patients who meet the POSEIDON Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number stratification group 4 criteria
In mild double stimualtion Shanghai protocol patients will be received Clomiphene citrate 25 mgday Ovumid Iran Hormone pharmaceutical Co Iran co-treatment and letrozole 25 mgday Femati Atipharmed Co Iran will be given from cycle day 3 Letrozole is given for 4 days and clomiphene citrate is used daily before the trigger day Patients take 150 IU of Human menopausal gonadotropin HMG Humegnan Darou Pakhsh Co Iran every other day beginning on cycle day 6 When one dominant follicle will reach 18 mm the final triggering will induce 34-36 h after 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran administration In luteal phase stimulation a total of 225 IU HMG and letrozole 25 mg will administered daily from3 to 5 days after oocyte retrieval Letrozole administration will be stopped when the dominant follicles reached 12 mm When one dominant follicle will reach 18 mm the final triggering will be induced with 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran
In the double GnRH- antagonist Duostim protocol both follicular and luteal phases stimulation will perform with 150-225 IU of recombinant FSH Gonal-F Merck-sereno Germany and HMG Humegnan Darou Pakhsh Co Iran in GnRH antagonist treatment The follicular stimulation will be started on day 2-3 of the menstrual Daily administration of 025 mg of GnRH antagonist Cetrotide Merck-Serono Germany will be started when the leading follicle are 13-14mm and continue until the day of the oocyte trigger When one follicle reached 17-18 mm ovulation will be triggered with 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran and oocyte retrieval will be performed after 34-36 hours Five days after the first oocyte retrieval a GnRH antagonist protocol identical to the first one will start When at least two follicles reached 17-18 mm the ovulation will be triggered with a subcutaneous bolus GnRH-agonist and the second oocyte retrieval will be performed
In all of groups all of embryos will be freeze and will be used in subsequent frozen embryo transfer FET cycles Endometrial preparation for FET cycle will perform with hormonal replacement therapy HRT cycle protocol
In mild double stimualtion Shanghai protocol patients will be received Clomiphene citrate 25 mgday Ovumid Iran Hormone pharmaceutical Co Iran co-treatment and letrozole 25 mgday Femati Atipharmed Co Iran will be given from cycle day 3 Letrozole is given for 4 days and clomiphene citrate is used daily before the trigger day Patients take 150 IU of Human menopausal gonadotropin HMG Humegnan Darou Pakhsh Co Iran every other day beginning on cycle day 6 When one dominant follicle will reach 18 mm the final triggering will induce 34-36 h after 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran administration In luteal phase stimulation a total of 225 IU HMG and letrozole 25 mg will administered daily from3 to 5 days after oocyte retrieval Letrozole administration will be stopped when the dominant follicles reached 12 mm When one dominant follicle will reach 18 mm the final triggering will be induced with 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran
In the double GnRH- antagonist Duostim protocol both follicular and luteal phases stimulation will perform with 150-225 IU of recombinant FSH Gonal-F Merck-sereno Germany and HMG Humegnan Darou Pakhsh Co Iran in GnRH antagonist treatment The follicular stimulation will be started on day 2-3 of the menstrual Daily administration of 025 mg of GnRH antagonist Cetrotide Merck-Serono Germany will be started when the leading follicle are 13-14mm and continue until the day of the oocyte trigger When one follicle reached 17-18 mm ovulation will be triggered with 05 cc of Buserelin acetate CinnaFact CinnaGen pharmaceutical Co Iran and oocyte retrieval will be performed after 34-36 hours Five days after the first oocyte retrieval a GnRH antagonist protocol identical to the first one will start When at least two follicles reached 17-18 mm the ovulation will be triggered with a subcutaneous bolus GnRH-agonist and the second oocyte retrieval will be performed
In all of groups all of embryos will be freeze and will be used in subsequent frozen embryo transfer FET cycles Endometrial preparation for FET cycle will perform with hormonal replacement therapy HRT cycle protocol
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