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Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes. (OXOART2)

Primary Purpose

Infertility, Female, Infertility

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OXO-001
Placebo
Sponsored by
OXOLIFE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Endometrial receptivity, Embryo implantation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fertimed s.r.o.
  • ISCARE centrum asistované reprodukce
  • IVF CUBE
  • Sanatorium PRONATAL
  • UNICA Prague s.r.o
  • Pronatal NORD
  • Klinika reprodukční medicíny a gynekologie
  • KRIOBANK Centrum Leczenia Niepłodności Ginekologia
  • ProCrea Swiss IVF Center s.r.o.
  • Provita Sp. z o.o.
  • VitroLive Sp. z o.o.
  • OVIklinika
  • Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna
  • Instituto Bernabeu
  • Fertty
  • Hospital Universitari Dexeus
  • Hospital Universitario Quirónsalud Barcelona
  • IVI Barcelona
  • IVI Bilbao
  • GINEFIV Madrid
  • Hospital Universitario Quirónsalud Madrid
  • Instituto Bernabeu Madrid
  • IVI Madrid
  • IVI Mallorca
  • Ginemed Sevilla
  • IVI Sevilla
  • IVI Valencia
  • IVI Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

OXO-001 200 mg

OXO-001 300 mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)

Secondary Outcome Measures

Positive blood pregnancy test
Percentage of women with positive blood pregnancy test
Vital pregnancy at 6 weeks
Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET
Early pregnancy loss rate
Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10-15 days post ET).
Adverse events
Incidence and severity of adverse events/serious adverse events
Hematology and biochemistry values
Changes from baseline in haematology and biochemistry values
Vital signs
Changes from baseline in heart rate (bpm)
Vital signs
Changes from baseline blood pressure mmHg

Full Information

First Posted
September 21, 2021
Last Updated
June 22, 2022
Sponsor
OXOLIFE
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1. Study Identification

Unique Protocol Identification Number
NCT05076032
Brief Title
Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.
Acronym
OXOART2
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OXOLIFE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Infertility
Keywords
Endometrial receptivity, Embryo implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to 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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OXO-001 200 mg
Arm Type
Experimental
Arm Description
Two tablets of 100 mg have to be taken once daily in the early morning.
Arm Title
OXO-001 300 mg
Arm Type
Experimental
Arm Description
Two tablets of 150 mg have to be taken once daily in the early morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two tablets have to be taken once daily in the early morning.
Intervention Type
Drug
Intervention Name(s)
OXO-001
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)
Time Frame
10 weeks post Embryo Transfer (ET)
Secondary Outcome Measure Information:
Title
Positive blood pregnancy test
Description
Percentage of women with positive blood pregnancy test
Time Frame
10 to 15 days post ET
Title
Vital pregnancy at 6 weeks
Description
Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET
Time Frame
6 weeks post ET
Title
Early pregnancy loss rate
Description
Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10-15 days post ET).
Time Frame
10 weeks post ET
Title
Adverse events
Description
Incidence and severity of adverse events/serious adverse events
Time Frame
From the first intake of the investigational product until 10 weeks post ET
Title
Hematology and biochemistry values
Description
Changes from baseline in haematology and biochemistry values
Time Frame
From the first intake of the investigational product until 10 weeks post ET
Title
Vital signs
Description
Changes from baseline in heart rate (bpm)
Time Frame
From the first intake of the investigational product until 10 weeks post ET
Title
Vital signs
Description
Changes from baseline blood pressure mmHg
Time Frame
From the first intake of the investigational product until 10 weeks post ET

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fertimed s.r.o.
City
Olomouc
Country
Czechia
Facility Name
ISCARE centrum asistované reprodukce
City
Praha
Country
Czechia
Facility Name
IVF CUBE
City
Praha
Country
Czechia
Facility Name
Sanatorium PRONATAL
City
Praha
Country
Czechia
Facility Name
UNICA Prague s.r.o
City
Praha
Country
Czechia
Facility Name
Pronatal NORD
City
Teplice
Country
Czechia
Facility Name
Klinika reprodukční medicíny a gynekologie
City
Zlín
Country
Czechia
Facility Name
KRIOBANK Centrum Leczenia Niepłodności Ginekologia
City
Białystok
Country
Poland
Facility Name
ProCrea Swiss IVF Center s.r.o.
City
Katowice
Country
Poland
Facility Name
Provita Sp. z o.o.
City
Katowice
Country
Poland
Facility Name
VitroLive Sp. z o.o.
City
Szczecin
Country
Poland
Facility Name
OVIklinika
City
Warszawa
Country
Poland
Facility Name
Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna
City
Warszawa
Country
Poland
Facility Name
Instituto Bernabeu
City
Alicante
Country
Spain
Facility Name
Fertty
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Dexeus
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Quirónsalud Barcelona
City
Barcelona
Country
Spain
Facility Name
IVI Barcelona
City
Barcelona
Country
Spain
Facility Name
IVI Bilbao
City
Leioa
Country
Spain
Facility Name
GINEFIV Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Quirónsalud Madrid
City
Madrid
Country
Spain
Facility Name
Instituto Bernabeu Madrid
City
Madrid
Country
Spain
Facility Name
IVI Madrid
City
Madrid
Country
Spain
Facility Name
IVI Mallorca
City
Palma De Mallorca
Country
Spain
Facility Name
Ginemed Sevilla
City
Sevilla
Country
Spain
Facility Name
IVI Sevilla
City
Sevilla
Country
Spain
Facility Name
IVI Valencia
City
Valencia
Country
Spain
Facility Name
IVI Zaragoza
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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