Clinical trial NCT05076032: Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility, Female
Infertility
Keywords: Endometrial receptivity
Embryo implantation
Lead sponsor: OXOLIFE
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 408
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 weeks post Embryo Transfer (ET)
Secondary outcomes:
measure: Positive blood pregnancy test
timeFrame: 10 to 15 days post ET
measure: Vital pregnancy at 6 weeks
timeFrame: 6 weeks post ET
measure: Early pregnancy loss rate
timeFrame: 10 weeks post ET
measure: Adverse events
timeFrame: From the first intake of the investigational product until 10 weeks post ET
measure: Hematology and biochemistry values
timeFrame: From the first intake of the investigational product until 10 weeks post ET
measure: Vital signs
timeFrame: From the first intake of the investigational product until 10 weeks post ET
measure: Vital signs
timeFrame: From the first intake of the investigational product until 10 weeks post ET
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Fertimed s.r.o.
city: Praha
country: Czechia
facility: ISCARE centrum asistované reprodukce
city: Praha
country: Czechia
facility: IVF CUBE
city: Praha
country: Czechia
facility: Sanatorium PRONATAL
city: Praha
country: Czechia
facility: UNICA Prague s.r.o
city: Teplice
country: Czechia
facility: Pronatal NORD
city: Zlín
country: Czechia
facility: Klinika reprodukční medicíny a gynekologie
city: Białystok
country: Poland
facility: KRIOBANK Centrum Leczenia Niepłodności Ginekologia
city: Katowice
country: Poland
facility: ProCrea Swiss IVF Center s.r.o.
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Szczecin
country: Poland
facility: VitroLive Sp. z o.o.
city: Warszawa
country: Poland
facility: OVIklinika
city: Warszawa
country: Poland
facility: Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna
city: Alicante
country: Spain
facility: Instituto Bernabeu
city: Barcelona
country: Spain
facility: Fertty
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitario Quirónsalud Barcelona
city: Barcelona
country: Spain
facility: IVI Barcelona
city: Leioa
country: Spain
facility: IVI Bilbao
city: Madrid
country: Spain
facility: GINEFIV Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Madrid
country: Spain
facility: Instituto Bernabeu Madrid
city: Madrid
country: Spain
facility: IVI Madrid
city: Palma De Mallorca
country: Spain
facility: IVI Mallorca
city: Sevilla
country: Spain
facility: Ginemed Sevilla
city: Sevilla
country: Spain
facility: IVI Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
city: Zaragoza
country: Spain
facility: IVI Zaragoza
Study officials:
affiliation: Oxolife S.L
name: Agnès Arbat, MD
role: STUDY_DIRECTOR
References: