Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Randomized Open-label Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an exploratory prospective randomized open-label and controlled trial to evaluate the potential benefit of r-hFSHr-hLH 21 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment
After signing informed consent form ICF all eligible participants will be randomly assigned in a 11 ratio to either treatment or control group and GnRH antagonist protocol will be used in both treatment and control groups
After signing informed consent form ICF all eligible participants will be randomly assigned in a 11 ratio to either treatment or control group and GnRH antagonist protocol will be used in both treatment and control groups
Detailed Description:
This will be an exploratory prospective randomized open-label and controlled trial to evaluate the potential benefit of r-hFSHr-hLH 21 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment
After signing informed consent form ICF all eligible participants will be randomly assigned in a 11 ratio to either treatment or control group and GnRH antagonist protocol will be used in both treatment and control groups
1 Treatment group The r-hFSH starting dose will be based on the patients profile and physicians experience r-hLH will be added at a ratio of 21 starting from day 1 of r-hFSH administration the dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patients ovarian response and the r-hFSH r-hLH dose will be 21 continuing to 2448 hours prior to trigger drug injection
2 Control group r-hFSH alone will be administrated for ovarian stimulation The r-hFSH starting dose will be based on the patients profile and physicians experience The dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patients ovarian response continuing to 2448 hours prior to trigger drug injection
The estimated treatment duration is 11 days from the first day of COS until 2448 h prior to trigger drug injection and this may vary depending on individual circumstances
Follicular development serum E2 and P levels will be monitored during COS according to the investigator sites ART practice until the criteria to administer trigger drug are met to induce final oocyte maturation Trigger drug administration is to be performed according to the sites routine clinical practice
Oocyte pick-up OPU IVFICSI ET and luteal phase support LPS will be performed according to the sites routine practice LPS will be started after oocyte retrieval in fresh embryo transfer
After signing informed consent form ICF all eligible participants will be randomly assigned in a 11 ratio to either treatment or control group and GnRH antagonist protocol will be used in both treatment and control groups
1 Treatment group The r-hFSH starting dose will be based on the patients profile and physicians experience r-hLH will be added at a ratio of 21 starting from day 1 of r-hFSH administration the dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patients ovarian response and the r-hFSH r-hLH dose will be 21 continuing to 2448 hours prior to trigger drug injection
2 Control group r-hFSH alone will be administrated for ovarian stimulation The r-hFSH starting dose will be based on the patients profile and physicians experience The dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patients ovarian response continuing to 2448 hours prior to trigger drug injection
The estimated treatment duration is 11 days from the first day of COS until 2448 h prior to trigger drug injection and this may vary depending on individual circumstances
Follicular development serum E2 and P levels will be monitored during COS according to the investigator sites ART practice until the criteria to administer trigger drug are met to induce final oocyte maturation Trigger drug administration is to be performed according to the sites routine clinical practice
Oocyte pick-up OPU IVFICSI ET and luteal phase support LPS will be performed according to the sites routine practice LPS will be started after oocyte retrieval in fresh embryo transfer
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