Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-02 @ 4:56 AM
Study NCT ID:
NCT05076032
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.
Sponsor:
OXOLIFE
Organization:
Study Overview
Official Title:
Phase II, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial to Assess Ongoing Pregnancy Rate With OXO-001 (200/300 mg) or Placebo at 10 Weeks Following Fresh Single Blastocyst Transfer From Donor Oocyte IVF/ICSI
Status:
COMPLETED
Status Verified Date:
2024-11
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:
OXOART2
Brief Summary:
The main objective of this clinical research trial is to test the efficacy of OXO-001 in a daily oral administration increasing the pregnancy rate in IVF/ICSI by preparing the uterus to receive the embryo.
Detailed Description:
Assisted reproductive techniques are the most common procedures to fulfill the desire for pregnancy in infertile women. Unfortunately, more than half of the assisted reproduction cycles result in implantation failure or early pregnancy loss, the two main causes of infertility and the most important unmet medical need in the field of infertility with current treatments.
This clinical trial aims to test the capacity of OXO-001 to enhance embryo implantation. It is a phase II, randomised, double-blind, parallel-group, placebo-controlled trial that will assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI.
This clinical trial aims to test the capacity of OXO-001 to enhance embryo implantation. It is a phase II, randomised, double-blind, parallel-group, placebo-controlled trial that will assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-000001-25 | EUDRACT_NUMBER | None | View |