Ginefiv S.L.
Madrid, Spain
Recruiting
A study to evaluate the effect of nolasiban on uterine contractions in women undergoing IVF or ICSI treatments
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study is being conducted to evaluate the effects of nolasiban on uterine contractility, which refers to the strength and frequency of the contractions or movements of the muscles in the uterus. The research involves women who are undergoing In Vitro Fertilization or Intracytoplasmic Sperm Injection, which are medical procedures used to assist with pregnancy when other methods have not been successful. During the trial, participants will receive either a dispersible tablet containing nolasiban or a placebo.
The investigation focuses on how different amounts of the medication affect the uterus and endocrine parameters, which are the various levels of hormones in the body. The process involves monitoring the body's response to two different dosing schedules over several days to see how the medication influences the muscular activity of the uterus and the hormonal balance.
The research process
The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- You must provide a signed informed consent, which is a written document where you agree to participate in the study after being told all the details.
- You must be in good physical and mental health as decided by the study doctor.
- You must be a woman between the ages of 18 and 42 years old.
- Your body mass index (BMI), which is a measure of your weight in relation to your height, must be between 18.5 and 35.0.
- You must be experiencing infertility, which means having difficulty becoming pregnant, specifically due to blocked or damaged fallopian tubes, unknown reasons, or a partner with male factor infertility (a condition where the male partner has difficulty contributing sperm to conception).
- You must be eligible for in vitro fertilization (IVF), a process where eggs are fertilized by sperm outside the body in a laboratory, or intracytoplasmic sperm injection (ICSI), a specialized form of IVF where a single sperm is injected directly into an egg.
- You must be willing to follow all study rules, including showing up for all scheduled appointments.
- You must agree to use barrier contraception, such as a male condom, or avoid vaginal intercourse from the start of your medication until the end of the study.
Who cannot join the trial?
36 criteria
- Having an active blood clot in an artery or vein, or a history of severe inflammation in a vein, known as thrombophlebitis.
- Having a current infection in the pelvis or uterus, such as endometritis (inflammation of the uterine lining), cervicitis (inflammation of the cervix), or pelvic inflammatory disease.
- Having any abnormal vital signs (such as blood pressure, heart rate, or temperature) that the doctor considers important.
- Having certain uterine issues that have not been resolved in the last year, including submucous fibroids (growths in the uterus that bulge into the cavity), intramural fibroids (growths within the muscular wall of the uterus) larger than 3 cm, uterine polyps (small growths on the lining), or any birth defects or acquired shapes of the uterus that make it hard to record uterine contractions.
- Being unable to get a clear ultrasound recording of the uterus (known as IC-EHG) after two attempts.
- Having a history of uterine surgery, such as a myomectomy (removal of fibroids) or a cesarean section (C-section).
- Having had procedures inside the uterus, such as a hysteroscopy (using a camera to look inside the uterus) or the removal of an intrauterine device (IUD), within the last 30 days.
- Having a history of procedures to block blood flow to the uterine arteries (uterine artery embolization) or using heat to treat uterine tissue (radiofrequency ablation).
- Suspected endometrial hyperplasia (overgrowth of the uterine lining) or intrauterine adhesions (scar tissue inside the uterus).
- Having abnormal results from a cervical cytology test (a Pap smear) within the last three years, unless the issue was resolved.
- Having cervical stenosis, which is a narrowing of the opening of the cervix.
- Having a known inherited or acquired condition that makes blood more likely to clot, known as thrombophilia.
- A history of difficult medical procedures involving the uterus, such as difficulties during embryo transfer or intrauterine insemination (placing sperm inside the uterus), including the need for cervical dilatation (widening the cervix).
- Being pregnant.
- Currently breastfeeding.
- Using any form of hormonal birth control, such as the pill, skin patches, injections, implants, or hormonal devices inside the uterus.
- Having unexplained vaginal bleeding.
- Having a recent or current heart problem, such as a myocardial infarction (heart attack), unstable chest pain (unstable angina), heart surgery, uncontrolled high blood pressure, irregular heartbeats (arrhythmia), or congestive heart failure (a condition where the heart cannot pump enough blood).
- Needing treatment with high doses of glucocorticoids (steroids used to reduce inflammation) or magnesium sulphate during the study.
- Using certain medications that could interfere with the study, including those that relax the uterus, those that cause the uterus to contract, sleep aids, sedatives, or regular use of NSAIDs (painkillers like aspirin).
- Using specific medications that are processed by certain proteins or enzymes in the body, such as certain cholesterol drugs or blood thinners.
- Having a history of chemotherapy (cancer treatment using drugs) or radiotherapy (cancer treatment using radiation), except for conditions related to pregnancy.
- Having abnormalities in hormone-producing glands (such as the thyroid, adrenal, or pancreas) or metabolic issues, unless they are well-controlled.
- A history of alcohol or drug abuse.
- Drinking more than 14 units of alcohol per week.
- Smoking more than 10 cigarettes per day in the last three months.
- Having an allergy to any ingredients used in the study medicines or having an allergy to peanuts or soy.
- Having any medical condition that prevents the use of estrogen or progestin (hormones).
- Having previously participated in this specific clinical trial.
- Using any experimental drugs that are not registered with health authorities in the last 3 months.
- Participating in another clinical trial at this time.
- Having tumors in the ovaries, breasts, uterus, or hormone-regulating glands.
- Having porphyria (a group of rare disorders that affect production of heme, a component of blood).
- Having jaundice (yellowing of the skin or eyes due to liver issues).
- Having moderate or severe problems with the adrenal, kidney, or liver functions.
- Having abnormal blood or urine test results, such as high levels of liver enzymes (AST or ALT), high bilirubin (a yellow substance from broken-down red blood cells), poor kidney function (low eGFR or high creatinine), or high levels of protein in the urine.
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Verified Verified IVI Barcelona S.L.
Barcelona, Spain
Trial locations
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Investigated drugs
Nolasiban is an oral medication taken in the form of a tablet that dissolves in the mouth. This study is testing how this medicine affects the contractions of the uterus.
What is already known about the treatment
Nolasiban - This medication is taken orally in the form of a tablet that dissolves quickly in the mouth or with liquid. Currently being studied in clinical trials, it is classified as an oxytocin receptor antagonist. It works by blocking the action of oxytocin, a natural hormone, at the cellular level to prevent the muscles of the uterus from contracting too strongly. This drug is being investigated for its potential to help manage uterine activity in specific pregnancy-related situations.
Investigated diseases
Infertility - This condition occurs when a person is unable to achieve pregnancy after regular unprotected sexual intercourse. It can be related to issues with the reproductive organs or hormonal imbalances. In the context of assisted reproduction, it may involve difficulties with egg release or sperm quality. The condition often leads to the need for specialized medical interventions to facilitate conception.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524896-22-00Protocol codeRPN-NLS02Estimated enrolment120 patientsSponsorReproNovo ApS
sourced from the EU Clinical Trials Register and site verification
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