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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Infertility, Female
• Intervention / Treatment: Drug: OXO-001; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia
    • Fertimed s.r.o.
  • Praha, Czechia
    • IVF CUBE
  • Praha, Czechia
    • ISCARE centrum asistované reprodukce
  • Praha, Czechia
    • Sanatorium PRONATAL
  • Praha, Czechia
    • UNICA Prague s.r.o
  • Teplice, Czechia
    • Pronatal NORD
  • Zlín, Czechia
    • Klinika reprodukční medicíny a gynekologie
• Poland
  • Białystok, Poland
    • KRIOBANK Centrum Leczenia Niepłodności Ginekologia
  • Katowice, Poland
    • ProCrea Swiss IVF Center s.r.o.
  • Katowice, Poland
    • Provita Sp. z o.o.
  • Szczecin, Poland
    • VitroLive Sp. z o.o.
  • Warszawa, Poland
    • OVIklinika
  • Warszawa, Poland
    • Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna
• Spain
  • Alicante, Spain
    • Instituto Bernabeu
  • Barcelona, Spain
    • IVI Barcelona
  • Barcelona, Spain
    • Fertty
  • Barcelona, Spain
    • Hospital Universitari Dexeus
  • Barcelona, Spain
    • Hospital Universitario Quirónsalud Barcelona
  • Leioa, Spain
    • IVI Bilbao
  • Madrid, Spain
    • IVI Madrid
  • Madrid, Spain
    • Ginefiv Madrid
  • Madrid, Spain
    • Hospital Universitario Quironsalud Madrid
  • Madrid, Spain
    • Instituto Bernabeu Madrid
  • Palma De Mallorca, Spain
    • IVI Mallorca
  • Sevilla, Spain
    • IVI Sevilla
  • Sevilla, Spain
    • Ginemed Sevilla
  • Valencia, Spain
    • IVI Valencia
  • Zaragoza, Spain
    • IVI Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OXO-001 200 mg; Two tablets of 100 mg have to be taken once daily in the early morning.	Drug: 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.
Experimental: OXO-001 300 mg; Two tablets of 150 mg have to be taken once daily in the early morning.	Drug: 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.
Placebo Comparator: Placebo; Two tablets have to be taken once daily in the early morning.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)	10 weeks post Embryo Transfer (ET)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive blood pregnancy test	Percentage of women with positive blood pregnancy test	10 to 15 days post ET
Vital pregnancy at 6 weeks	Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET	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).	10 weeks post ET
Adverse events	Incidence and severity of adverse events/serious adverse events	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	From the first intake of the investigational product until 10 weeks post ET
Vital signs	Changes from baseline in heart rate (bpm)	From the first intake of the investigational product until 10 weeks post ET
Vital signs	Changes from baseline blood pressure mmHg	From the first intake of the investigational product until 10 weeks post ET

Collaborators and Investigators

• Sponsor: OXOLIFE

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Endometrial receptivity; Embryo implantation
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: OXO-001-201; 2021-000001-25 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No