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

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076032
• Other study ID #: OXO-001-201
• Secondary ID: 2021-000001-25
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2024
• Source: OXOLIFE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
OXOLIFE

Countries where clinical trial is conducted

Czechia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)	10 weeks post Embryo Transfer (ET)
Secondary	Positive blood pregnancy test	Percentage of women with positive blood pregnancy test	10 to 15 days post ET
Secondary	Vital pregnancy at 6 weeks	Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET	6 weeks post ET
Secondary	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
Secondary	Adverse events	Incidence and severity of adverse events/serious adverse events	From the first intake of the investigational product until 10 weeks post ET
Secondary	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
Secondary	Vital signs	Changes from baseline in heart rate (bpm)	From the first intake of the investigational product until 10 weeks post ET
Secondary	Vital signs	Changes from baseline blood pressure mmHg	From the first intake of the investigational product until 10 weeks post ET