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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility, Female, Infertility

Intervention / Treatment
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* Drug: OXO-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXO-001 200 mg<br>Two tablets of 100 mg have to be taken once daily in the early morning. | Drug: OXO-001<br>* 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.<br>|
| Experimental: OXO-001 300 mg<br>Two tablets of 150 mg have to be taken once daily in the early morning. | Drug: OXO-001<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Two tablets have to be taken once daily in the early morning. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Rate of subjects with uterine pregnancy and a foetal heartbeat confirmed by ultrasound (US) | 10 weeks post Embryo Transfer (ET) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive blood pregnancy test | Percentage of women with positive blood pregnancy test | 10 to 15 days post ET | 
| Vital pregnancy at 6 weeks | Intra-uterine pregnancy with foetal heartbeat at 6 weeks post ET | 6 weeks post ET | 
| 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 | 
| Adverse events | Incidence and severity of adverse events/serious adverse events | From the first intake of the investigational product until 10 weeks post ET | 
| 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 | 
| Vital signs | Changes from baseline in heart rate (bpm) | From the first intake of the investigational product until 10 weeks post ET | 
| Vital signs | Changes from baseline blood pressure mmHg | From the first intake of the investigational product until 10 weeks post ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial receptivity, Embryo implantation