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

Sponsor

OXOLIFE (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05076032

Collaborator

(none)

351

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Infertility	Drug: OXO-001 Drug: Placebo	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

351 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy rate [10 weeks post Embryo Transfer (ET)]
Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US)

Secondary Outcome Measures

Positive blood pregnancy test [10 to 15 days post ET]
Percentage of women with positive blood pregnancy test
Vital pregnancy at 6 weeks [6 weeks post ET]
Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET
Early pregnancy loss rate [10 weeks post ET]
Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10-15 days post ET).
Adverse events [From the first intake of the investigational product until 10 weeks post ET]
Incidence and severity of adverse events/serious adverse events
Hematology and biochemistry values [From the first intake of the investigational product until 10 weeks post ET]
Changes from baseline in haematology and biochemistry values
Vital signs [From the first intake of the investigational product until 10 weeks post ET]
Changes from baseline in heart rate (bpm)
Vital signs [From the first intake of the investigational product until 10 weeks post ET]
Changes from baseline blood pressure mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Fertimed s.r.o.	Olomouc	Czechia
2	ISCARE centrum asistované reprodukce	Praha	Czechia
3	IVF CUBE	Praha	Czechia
4	Sanatorium PRONATAL	Praha	Czechia
5	UNICA Prague s.r.o	Praha	Czechia
6	Pronatal NORD	Teplice	Czechia
7	Klinika reprodukční medicíny a gynekologie	Zlín	Czechia
8	KRIOBANK Centrum Leczenia Niepłodności Ginekologia	Białystok	Poland
9	ProCrea Swiss IVF Center s.r.o.	Katowice	Poland
10	Provita Sp. z o.o.	Katowice	Poland
11	VitroLive Sp. z o.o.	Szczecin	Poland
12	OVIklinika	Warszawa	Poland
13	Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna	Warszawa	Poland
14	Instituto Bernabeu	Alicante	Spain
15	Fertty	Barcelona	Spain
16	Hospital Universitari Dexeus	Barcelona	Spain
17	Hospital Universitario Quirónsalud Barcelona	Barcelona	Spain
18	IVI Barcelona	Barcelona	Spain
19	IVI Bilbao	Leioa	Spain
20	GINEFIV Madrid	Madrid	Spain
21	Hospital Universitario Quirónsalud Madrid	Madrid	Spain
22	Instituto Bernabeu Madrid	Madrid	Spain
23	IVI Madrid	Madrid	Spain
24	IVI Mallorca	Palma De Mallorca	Spain
25	Ginemed Sevilla	Sevilla	Spain
26	IVI Sevilla	Sevilla	Spain
27	IVI Valencia	Valencia	Spain
28	IVI Zaragoza	Zaragoza	Spain

Sponsors and Collaborators

OXOLIFE

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

OXOLIFE

ClinicalTrials.gov Identifier:

NCT05076032

Other Study ID Numbers:

OXO-001-201
2021-000001-25

First Posted:

Oct 13, 2021

Last Update Posted:

Jun 23, 2022

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by OXOLIFE

Endometrial receptivity

Embryo implantation

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Jun 23, 2022