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

NCT05076032 | Completed Phase 2

• 2 other identifiers: OXO-001-2012021-000001-25
• Study Type: interventional
• Target: 408
• Locations: 3 countries
• Sites: 28

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.

Conditions

Infertility, Female; Infertility

Keywords

Endometrial receptivity; Embryo implantation

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

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

  10 weeks post Embryo Transfer (ET)

Secondary Outcomes (7)

• Positive blood pregnancy test

  10 to 15 days post ET

• Vital pregnancy at 6 weeks

  6 weeks post ET

• Early pregnancy loss rate

  10 weeks post ET

• Adverse events

  From the first intake of the investigational product until 10 weeks post ET

• Hematology and biochemistry values

  From the first intake of the investigational product until 10 weeks post ET

Study Arms (3)

OXO-001 200 mg

EXPERIMENTAL

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

Drug: OXO-001

OXO-001 300 mg

EXPERIMENTAL

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

Drug: OXO-001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OXO-001 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-001 200 mg; OXO-001 300 mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OXOLIFE: lead

Study Sites (28)

Fertimed s.r.o.

Olomouc, Czechia

Location

ISCARE centrum asistované reprodukce

Prague, Czechia

Location

IVF CUBE

Prague, Czechia

Location

Sanatorium PRONATAL

Prague, Czechia

Location

UNICA Prague s.r.o

Prague, Czechia

Location

Pronatal NORD

Teplice, Czechia

Location

Klinika reprodukční medicíny a gynekologie

Zlín, Czechia

Location

KRIOBANK Centrum Leczenia Niepłodności Ginekologia

Bialystok, Poland

Location

ProCrea Swiss IVF Center s.r.o.

Katowice, Poland

Location

Provita Sp. z o.o.

Katowice, Poland

Location

VitroLive Sp. z o.o.

Szczecin, Poland

Location

OVIklinika

Warsaw, Poland

Location

Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna

Warsaw, Poland

Location

Instituto Bernabeu

Alicante, Spain

Location

Fertty

Barcelona, Spain

Location

Hospital Universitari Dexeus

Barcelona, Spain

Location

Hospital Universitario Quirónsalud Barcelona

Barcelona, Spain

Location

IVI Barcelona

Barcelona, Spain

Location

IVI Bilbao

Leioa, Spain

Location

GINEFIV Madrid

Madrid, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

Location

Instituto Bernabeu Madrid

Madrid, Spain

Location

IVI Madrid

Madrid, Spain

Location

IVI Mallorca

Palma de Mallorca, Spain

Location

Ginemed Sevilla

Seville, Spain

Location

IVI Sevilla

Seville, Spain

Location

IVI Valencia

Valencia, Spain

Location

IVI Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Agnès Arbat, MD

  Oxolife S.L

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 13, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CZ (7); PL (6); ES (15)