Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.

NCT ID: NCT05076032

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-12-01

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.

Conditions

Infertility, Female; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OXO-001 200 mg

Two tablets of 100 mg have to be taken once daily in the early morning.

Group Type: EXPERIMENTAL

OXO-001

Intervention Type: DRUG

OXO-001 oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks approximately.

OXO-001 300 mg

Two tablets of 150 mg have to be taken once daily in the early morning.

Group Type: EXPERIMENTAL

OXO-001

Intervention Type: DRUG

OXO-001 oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks approximately.

Placebo

Two tablets have to be taken once daily in the early morning.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks, approximately.

Interventions

OXO-001

OXO-001 oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks approximately.

Intervention Type: DRUG

Placebo

Placebo oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks, approximately.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntary informed consent.
• Infertile female subjects indicated for egg donor programme in the context of ART.
• Subjects aged ≥ 18 to ≤ 45 years at screening.
• Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2.
• Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening.
• Planned transfer of a fresh single blastocyst from a donated egg.
• Good quality sperm.
• Planned endometrial preparation and luteal support.

Exclusion Criteria

• History of two or more failed in-vitro fertilisation (IVF) / intra-cytoplasmic sperm injection (ICSI) cycles after embryo transfer of donor oocyte during the last attempts prior to the trial.
• Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives.
• Abnormal haemorrhage of the reproductive tract of undetermined origin.
• Endometrial biopsy or endometrial local injury within one month prior to screening.
• Diagnosis of severe endometriosis and/or adenomyosis.
• Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results.
• Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
• Systemic disease which might interfere with the purpose of the trial.
• Any malignant neoplasm.
• Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting.
• History of uncontrolled hypertension.
• Known hypersensitivity to any component of the IP used in this trial.
• Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
• History (within 12 months) of or known current problems with alcohol or substance abuse.
• Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
• Previous treatment with the IP of this trial at any time or participation in another clinical trial within the past 3 months prior to screening.
• Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator.
• Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

OXOLIFE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnès Arbat, MD

Role: STUDY_DIRECTOR

Oxolife S.L

Locations

Fertimed s.r.o.

Olomouc, , Czechia

ISCARE centrum asistované reprodukce

Prague, , Czechia

IVF CUBE

Prague, , Czechia

Sanatorium PRONATAL

Prague, , Czechia

UNICA Prague s.r.o

Prague, , Czechia

Pronatal NORD

Teplice, , Czechia

Klinika reprodukční medicíny a gynekologie

Zlín, , Czechia

KRIOBANK Centrum Leczenia Niepłodności Ginekologia

Bialystok, , Poland

ProCrea Swiss IVF Center s.r.o.

Katowice, , Poland

Provita Sp. z o.o.

Katowice, , Poland

VitroLive Sp. z o.o.

Szczecin, , Poland

OVIklinika

Warsaw, , Poland

Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna

Warsaw, , Poland

Instituto Bernabeu

Alicante, , Spain

Fertty

Barcelona, , Spain

Hospital Universitari Dexeus

Barcelona, , Spain

Hospital Universitario Quirónsalud Barcelona

Barcelona, , Spain

IVI Barcelona

Barcelona, , Spain

IVI Bilbao

Leioa, , Spain

GINEFIV Madrid

Madrid, , Spain

Hospital Universitario Quirónsalud Madrid

Madrid, , Spain

Instituto Bernabeu Madrid

Madrid, , Spain

IVI Madrid

Madrid, , Spain

IVI Mallorca

Palma de Mallorca, , Spain

Ginemed Sevilla

Seville, , Spain

IVI Sevilla

Seville, , Spain

IVI Valencia

Valencia, , Spain

IVI Zaragoza

Zaragoza, , Spain

Countries

Czechia; Poland; Spain

Other Identifiers

2021-000001-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OXO-001-201

Identifier Type: -

Identifier Source: org_study_id