Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04416607
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2020-05-26
Brief Title:
Corifollitropin Alpha and Ovarian Response
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate FORT
Status:
COMPLETED
Status Verified Date:
2020-06
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:
None
Brief Summary:
Objective To study whether an administration of corifollitropin alpha modifies the follicular cohort measured by Follicular Output Rate FORT compared to human menopausal gonadotropin HMG in infertile patients undergoing in vitro fertilisation IVF
MM 306 infertile patients undergoing in vitro fertilisation IVF Ovarian stimulation protocol will be performed with a single dose of 100 μg 60kg or 150 μg 60kg corifollitropin alpha in group 1 n147 and 150-300 IUday human menopausal gonadotropin HMG according to age antimullerian hormone AMH level and antral follicle count AFC in group 2 n150
Moreover FORT will be calculated as the ratio of pre-ovulatory follicle 16-22 mm in diameter count on day of HCG100small antral follicle 3-8 mm count at baseline
MM 306 infertile patients undergoing in vitro fertilisation IVF Ovarian stimulation protocol will be performed with a single dose of 100 μg 60kg or 150 μg 60kg corifollitropin alpha in group 1 n147 and 150-300 IUday human menopausal gonadotropin HMG according to age antimullerian hormone AMH level and antral follicle count AFC in group 2 n150
Moreover FORT will be calculated as the ratio of pre-ovulatory follicle 16-22 mm in diameter count on day of HCG100small antral follicle 3-8 mm count at baseline
Detailed Description:
Patients will be allocated for convenience into two groups those who would receive corifollitropin alpha Group 1 or HMG Group 2
Ovarian stimulation protocol will be performed with a single dose of 100 μg 60 kg or 150 μg 60 kg of corifollitropin alpha Elonva Schering-Plough Brazil in group 1 which could be followed by daily administration of HMG beginning on day 8 if necessary in group 2 150-300 IUday HMG menotropin Menopur Ferring Brazil will be administered starting on cycle day 3 according to age AMH level and AFC plus gonadotropin-releasing hormone antagonist co-treatment Ganirelix 25 mcgday Orgalutran Schering-Plough Brazil in a flexible protocol at least 1 follicle 14 mm or 3 or more follicles 12 mm Doses will be adjusted as needed by the patient according to the ultrasound which is performed with a 6 MHz multifrequency transvaginal probe Toshiba Japan The criterion for HCG administration 5000 IU Choriomon Biopharma Brazil will be at least three follicles greater than 17 mm and then 36 hours later transvaginal oocyte retrieval was performed After 3 or 5 days one or two good-quality embryos will be transferred It will be performed intracytoplasmic sperm injection ICSI instead of conventional IVF when major male factor is presented
Primary outcome measure is FORT Secondary outcome measures include number of oocytes retrieved MII duration of stimulation number of embryos embryo quality and clinical pregnancy rate Adverse events such as ovarian hyperstimulation syndrome OHSS or drug-related complications are also monitored
Ovarian stimulation protocol will be performed with a single dose of 100 μg 60 kg or 150 μg 60 kg of corifollitropin alpha Elonva Schering-Plough Brazil in group 1 which could be followed by daily administration of HMG beginning on day 8 if necessary in group 2 150-300 IUday HMG menotropin Menopur Ferring Brazil will be administered starting on cycle day 3 according to age AMH level and AFC plus gonadotropin-releasing hormone antagonist co-treatment Ganirelix 25 mcgday Orgalutran Schering-Plough Brazil in a flexible protocol at least 1 follicle 14 mm or 3 or more follicles 12 mm Doses will be adjusted as needed by the patient according to the ultrasound which is performed with a 6 MHz multifrequency transvaginal probe Toshiba Japan The criterion for HCG administration 5000 IU Choriomon Biopharma Brazil will be at least three follicles greater than 17 mm and then 36 hours later transvaginal oocyte retrieval was performed After 3 or 5 days one or two good-quality embryos will be transferred It will be performed intracytoplasmic sperm injection ICSI instead of conventional IVF when major male factor is presented
Primary outcome measure is FORT Secondary outcome measures include number of oocytes retrieved MII duration of stimulation number of embryos embryo quality and clinical pregnancy rate Adverse events such as ovarian hyperstimulation syndrome OHSS or drug-related complications are also monitored
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