Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466486
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-29
Brief Title:
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Randomised Partially Double-blind Placebo-controlled Parallel-group Exploratory Trial to Investigate the Effect of FE999302 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Celestial-1
Brief Summary:
This is a phase 1b clinical trial with Choriogonadotropin beta FE999302 and Follitropin delta Rekovelle
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 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
Detailed Description:
None
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