Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511791
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Parallel-group Exploratory Trial to Investigate the Effect of FE 999302 When Administered During Different Time Intervals in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol
Status:
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:
Celestial-2
Brief Summary:
This is a phase 1b clinical trial with Choriogonadotropin beta FE999302 and Follitropin delta Rekovelle The trial is a randomised double blind placebo controlled parallel group exploratory trial investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol
Detailed Description:
The trial is multicentre randomized partially double-blind placebo-controlled parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin
The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation the number of stimulation days and oocytes retrieved the number of metaphase II oocytes and fertilised oocytes number of blastocysts on day 5 number of cryopreserved blastocysts endometrial thickness at eos positive bhcg rate clinical pregnancy vital pregnancy and ongoing pregnancy
The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation the number of stimulation days and oocytes retrieved the number of metaphase II oocytes and fertilised oocytes number of blastocysts on day 5 number of cryopreserved blastocysts endometrial thickness at eos positive bhcg rate clinical pregnancy vital pregnancy and ongoing pregnancy
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