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CompletedPhase 2

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

Key facts

Who runs it
OXOLIFE
Where
Czechia, Poland, and Spain28 sites in 3 countriesChoose a country to see its sites
Status
Completed
Phase
Phase 2
People taking part
408 people enrolled
Started
1 Sept 2021
Ended
1 Dec 2023
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • OXO-001
  • Placebo
Record updated
12 November 2024

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • Endometrial biopsy or endometrial local injury within one month prior to screening
  • 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
  • Abnormal haemorrhage of the reproductive tract of undetermined origin
  • Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
  • 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
  • Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol
  • Relevant clinically significant abnormality in the results of safety laboratory tests at screening
  • Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives
  • Diagnosis of severe endometriosis and/or adenomyosis
  • History (within 12 months) of or known current problems with alcohol or substance abuse
  • 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

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • OXO-001 200 mgTreatment being tested

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

    Treatment: OXO-001

  • OXO-001 300 mgTreatment being tested

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

    Treatment: OXO-001

  • PlaceboPlacebo, for comparison

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
12 November 2024