Infertility, FemalePhase 2OXOART2NCT05076032
Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.
A Phase 2 study testing OXO-001 in people with Infertility, Female and Infertility, run by OXOLIFE at 28 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Infertility
- What is being tested?
- OXO-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 1 Sep 2021to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Spain15 sites
Instituto Bernabeu
Alicante
Fertty
Barcelona
Hospital Universitari Dexeus
Barcelona
Hospital Universitario Quirónsalud Barcelona
Barcelona
IVI Barcelona
Barcelona
IVI Bilbao
Leioa
GINEFIV Madrid
Madrid
Hospital Universitario Quirónsalud Madrid
Madrid
Instituto Bernabeu Madrid
Madrid
IVI Madrid
Madrid
IVI Mallorca
Palma de Mallorca
Ginemed Sevilla
Seville
IVI Sevilla
Seville
IVI Valencia
Valencia
IVI Zaragoza
Zaragoza
Czechia7 sites
Fertimed s.r.o.
Olomouc
ISCARE centrum asistované reprodukce
Prague
IVF CUBE
Prague
Sanatorium PRONATAL
Prague
UNICA Prague s.r.o
Prague
Pronatal NORD
Teplice
Klinika reprodukční medicíny a gynekologie
Zlín
Poland6 sites
KRIOBANK Centrum Leczenia Niepłodności Ginekologia
Bialystok
ProCrea Swiss IVF Center s.r.o.
Katowice
Provita Sp. z o.o.
Katowice
VitroLive Sp. z o.o.
Szczecin
OVIklinika
Warsaw
Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna
Warsaw
About this study
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
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.
Read the 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
- Being tested
- OXO-001, Placebo
- Keywords
- Endometrial receptivity, Embryo implantation
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXO-001Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| OXO-001 200 mg | Experimental | Two tablets of 100 mg have to be taken once daily in the early morning. Receives: Drug: OXO-001 |
| OXO-001 300 mg | Experimental | Two tablets of 150 mg have to be taken once daily in the early morning. Receives: Drug: OXO-001 |
| Placebo | Placebo comparator | Two tablets have to be taken once daily in the early morning. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)
Measured: 10 weeks post Embryo Transfer (ET)
Secondary outcomes (7)
Positive blood pregnancy test
Percentage of women with positive blood pregnancy test
Measured: 10 to 15 days post ET
Vital pregnancy at 6 weeks
Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET
Measured: 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).
Measured: 10 weeks post ET
Adverse events
Incidence and severity of adverse events/serious adverse events
Measured: From the first intake of the investigational product until 10 weeks post ET
Hematology and biochemistry values
Changes from baseline in haematology and biochemistry values
Measured: From the first intake of the investigational product until 10 weeks post ET
Vital signs
Changes from baseline in heart rate (bpm)
Measured: From the first intake of the investigational product until 10 weeks post ET
Vital signs
Changes from baseline blood pressure mmHg
Measured: From the first intake of the investigational product until 10 weeks post ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- OXOLIFE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnès Arbat, MD, Study director, Oxolife S.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076032
- Sponsor's protocol ID
- OXO-001-201
- Other IDs
- 2021-000001-25
- Acronym
- OXOART2
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05076032
- Acronym / sponsor ID
- OXOART2 / OXO-001-201
- Conditions
- Infertility, Female, Infertility
- Keywords
- Endometrial receptivity, Embryo implantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- OXOLIFEIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| OXO-001 200 mg | Experimental | Drug: OXO-001Two tablets of 100 mg have to be taken once daily in the early morning. |
| OXO-001 300 mg | Experimental | Drug: OXO-001Two tablets of 150 mg have to be taken once daily in the early morning. |
| Placebo | Placebo comparator | Drug: PlaceboTwo tablets have to be taken once daily in the early morning. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OXO-001OXO-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. | Drug | OXO-001 200 mg, OXO-001 300 mg |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Ongoing pregnancy rate
Time frame: 10 weeks post Embryo Transfer (ET)
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)
7 secondary outcomes
Positive blood pregnancy test
Time frame: 10 to 15 days post ET
Vital pregnancy at 6 weeks
Time frame: 6 weeks post ET
Early pregnancy loss rate
Time frame: 10 weeks post ET
Adverse events
Time frame: From the first intake of the investigational product until 10 weeks post ET
Hematology and biochemistry values
Time frame: From the first intake of the investigational product until 10 weeks post ET
Vital signs
Time frame: From the first intake of the investigational product until 10 weeks post ET
Vital signs
Time frame: From the first intake of the investigational product until 10 weeks post ET
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnès Arbat, MD study director
Oxolife S.L
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OXO-001 in people with Infertility, Female and Infertility, run by OXOLIFE at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Spain, Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 10 weeks post Embryo Transfer (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.