Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778331
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-03-21
First Post:
2023-02-28
Brief Title:
The Difference Between POSEIDON Group 3 and Group 4 as Regards IVF
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Difference Between POSEIDON Group 3 and Group 4 as Regards IVF
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-03
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:
POSEIDON
Brief Summary:
prospective observational study over POSEIDON group 3 and POSEIDON group 4 with antagonist protocol for clinical pregnancy rate outcomes
Detailed Description:
Type of study prospective observational study
Study setting Ain Shams University Maternity Hospital IVF unit Specialized IVF centers in GIZAH
Study period Until all needed patients have been recruited about 6 months from start of the study
Study population women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSIIVF
Sampling method patients will be divided in 2 groups Group A Poseidon group 3 Group B Poseidon group 4
Sample size The study will be conducted on 340 patients
Sample justification Using PASS 15 program for sample size calculation setting power at 80 and α-error at 005 and assuming clinical pregnancy rate of 213 for Poseidon group 3 and 103 for Poseidon group 4 sample size of 170 women per group will be needed to detect difference between groups RK abdullah 2020
Ethical consideration The study will be done after the approval of the ethical committee of the department of obstetrics and gynecology faculty of medicine Ain Shams University Informed consent will be taken from all participants before recruitment in the study and after explaining the purpose and procedures of the study The investigator will obtain the written signed informed consent of each subject prior to performing Specific procedures on the subject The investigator will retain the original signed informed consent form The study will be based on the investigator self-funding
Study procedure
1 Full history will be taken from targeted women personal previous obstetric menstrual surgical previous ICSI
2 Labs will be revised especially AMH FSH LH E2 prolactin TSH
3 AFC on day 2 or 3 of menses
4 Full labs for chronic disease will be revised to exclude women with any chronic disease
5 Ultrasound at least to exclude any anatomical uterine problem
6 HSG
7 Women who will be categorized as Poseidon group 3 Group A and Poseidon group 4 Group B
8 They will be given after that antagonist protocol with dose of HMGFSH 300-450 IU per day Gonapure 150 IU -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt will be given from 2nd day of menstruation per day as starting dose then on 7th day Cetrotide 025 -Cetrorelix an anti-gonadotropin releasing hormone- MERCK SORONO-Germany will be given daily till triggering US will be done to evaluate follicular size from 7th day if it will be 18 cm or more for at least 2 follicles then Chorimon 5000 iu-Choriogonadotropin Alfa-IBSA-Switzerland of total dose 10000 IU will be given then ovum pick up with be done after 35 h of triggering ovulation BC Tarlatzis 2006
9 Assessment of embryo quality by embryologist on day 2 and day 3 to grade embryos and also checking of blastocyst formation on day 5
10 Embryo transfer ET will be done when it is on day 3 or day 5 based on the number and quality of available embryos
Study setting Ain Shams University Maternity Hospital IVF unit Specialized IVF centers in GIZAH
Study period Until all needed patients have been recruited about 6 months from start of the study
Study population women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSIIVF
Sampling method patients will be divided in 2 groups Group A Poseidon group 3 Group B Poseidon group 4
Sample size The study will be conducted on 340 patients
Sample justification Using PASS 15 program for sample size calculation setting power at 80 and α-error at 005 and assuming clinical pregnancy rate of 213 for Poseidon group 3 and 103 for Poseidon group 4 sample size of 170 women per group will be needed to detect difference between groups RK abdullah 2020
Ethical consideration The study will be done after the approval of the ethical committee of the department of obstetrics and gynecology faculty of medicine Ain Shams University Informed consent will be taken from all participants before recruitment in the study and after explaining the purpose and procedures of the study The investigator will obtain the written signed informed consent of each subject prior to performing Specific procedures on the subject The investigator will retain the original signed informed consent form The study will be based on the investigator self-funding
Study procedure
1 Full history will be taken from targeted women personal previous obstetric menstrual surgical previous ICSI
2 Labs will be revised especially AMH FSH LH E2 prolactin TSH
3 AFC on day 2 or 3 of menses
4 Full labs for chronic disease will be revised to exclude women with any chronic disease
5 Ultrasound at least to exclude any anatomical uterine problem
6 HSG
7 Women who will be categorized as Poseidon group 3 Group A and Poseidon group 4 Group B
8 They will be given after that antagonist protocol with dose of HMGFSH 300-450 IU per day Gonapure 150 IU -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt will be given from 2nd day of menstruation per day as starting dose then on 7th day Cetrotide 025 -Cetrorelix an anti-gonadotropin releasing hormone- MERCK SORONO-Germany will be given daily till triggering US will be done to evaluate follicular size from 7th day if it will be 18 cm or more for at least 2 follicles then Chorimon 5000 iu-Choriogonadotropin Alfa-IBSA-Switzerland of total dose 10000 IU will be given then ovum pick up with be done after 35 h of triggering ovulation BC Tarlatzis 2006
9 Assessment of embryo quality by embryologist on day 2 and day 3 to grade embryos and also checking of blastocyst formation on day 5
10 Embryo transfer ET will be done when it is on day 3 or day 5 based on the number and quality of available embryos
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None