PENTOXIFYLLINE for Oligospermia|Asthenozoospermia|Male infertility

Inclusion criteria

• {"criterion_text":"- Written informed consent form signed by the participant couple"}
• {"criterion_text":"- Unable to conceive for more than 6 months and less than 24 months, despite regular and adequate unprotected sexual intercourse."}
• {"criterion_text":"- Willing and able to comply with the protocol."}
• {"criterion_text":"- Females subjects with the following criteria: • Age ≥ 18 and ≤ 38 years. • Regular spontaneous menstrual cycles with a 25 to 35 day length (intercycle variation less than 5 days) within the last six cycles before first visit. • Normal uterine cavity shown on transvaginal sonography. • Normal ovarian reserve, demonstrated by AMH ≥ 0,8 ng/ml (valid result within 4 months before inclusion) • Antral follicle count (sum of both ovaries) ≥ 6"}
• {"criterion_text":"- Male subjects with the following criteria: • Age ≥ 18 and ≤ 50 years. • Spermiogram with semen volume ≥ 1mL, concentration > 11 M/mL, < 42% total mobility and normal forms ≥ 2% (valid result within 4 months before inclusion)"}

Exclusion criteria

• {"criterion_text":"- Body mass Index (BMI) < 18 and ≥ 32 kg/m²."}
• {"criterion_text":"- History of cerebral or retinal hemorrhage, acute myocardial infarction."}
• {"criterion_text":"- In females: Prohibited concomitant intravaginal products or procedures."}
• {"criterion_text":"- Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP."}
• {"criterion_text":"- Employees of the investigator or trial center, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial center, as well as family members of the employees or the principal investigator."}
• {"criterion_text":"- Patients with severe coronary artery disease, when in the physician’s judgement myocardial stimulation might prove harmful."}
• {"criterion_text":"- Patients with severe hepatic and renal impairment."}
• {"criterion_text":"- Patients without adequate laboratory parameters according to the normal ranges of local laboratory (valid results within 4 months before inclusion)."}
• {"criterion_text":"- Female risk factors of infertility defined by any of the following: • Absence of any or both ovaries. • Abnormal uterine cavity assessed by transvaginal sonography. Specially, submucosal fibroids, intramural fibroids affecting the uterine cavity (any size), more than 5 intramural fibroids ≥ 4 cm in diameter, or more than 6 intramural fibroids of any size. Women with any subserosal fibroid ≥ 8cm will also be excluded. • Risk factors for fallopian tube obstruction as abdominal surgery, diseases such as endometriosis, tuberculosis, ruptured appendix or peritonitis, Pelvic Inflammatory Disease (PID), Chlamydia and gonorrhea. • Antecedents of long-term amenorrhea, polycystic ovarian syndrome, type III or IV endometriosis, or fallopian tube obstruction. • Previous gynecological surgery, excluding caesarean section or myomectomy within predefined limits. • For women, prohibited concomitant therapies within 28 days before enrolled into the study until last treatment visit: sex hormones, selective estrogen receptor modulators, aromatase inhibitors or oral pentoxifilline. • Two or more clinical or preclinical spontaneous miscarriages. • Lactation or pregnancy. • Known abnormal karyotype"}
• {"criterion_text":"- Male risk factors of infertility defined by any of the following: • Vasectomy • Known genetic abnormalities related to infertility: i. Endocrine or systemic disorders causing hypergonadotropic hypogonadism (either, congenital or acquired). ii. Known abnormal karyotype • Previously diagnosed varicocele • The use of certain drugs (e.g., anabolic steroids, antineoplastic agents, erythromycin, tetracycline, gentamycin). • Viral process with fever ≥ 38ºC in the past 70 days"}
• {"criterion_text":"- People committed to an institution by virtue of an order issued either by the judicial or other authorities."}
• {"criterion_text":"- Reasonable expectation that the subject will not be able to satisfactorily complete the study: • History of current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent. • History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements. • Receipt of any investigational drug within three months of screening visit. • Previous enrolment in this trial. • Documented noncompliance. • Any other condition of the subject that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize subject’s safety or compliance to protocol requirements."}
• {"criterion_text":"- Patients with peptic ulcers or recent history thereof."}
• {"criterion_text":"- Patients with haemorrhage (e.g. extensive retinal bleeding) or at risk of increased bleeding"}
• {"criterion_text":"- Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks entry in the study and during it."}
• {"criterion_text":"- Couples who had any previous assisted reproductive technology (ART) cycle (in vitro fertilization, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial."}
• {"criterion_text":"- Active hepatitis B, C, HIV, genital herpes, Chlamydia, Gonorrhea or Syphilis infection."}
• {"criterion_text":"- History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy."}

Primary endpoints

• {"endpoint_text":"- Rate of clinical pregnancies defined as intrauterine pregnancy with confirmed fetal heartbeat by the 6-8th week of gestation.","definition_or_measurement_approach":"Clinical pregnancy defined as intrauterine pregnancy with confirmed heartbeat by the 6th-8th weeks of gestation; measured as rate of clinical pregnancies up to three treatment cycles."}

Secondary endpoints

• {"endpoint_text":"- Rate of Biochemical pregnancy: positive pregnancy test (blood β-hCG)","definition_or_measurement_approach":"Positive serum β-hCG test."}
• {"endpoint_text":"- Rate of Pregnancy loss: nonviable intrauterine pregnancy up to 20 weeks gestation","definition_or_measurement_approach":"Nonviable intrauterine pregnancy up to 20 weeks gestation."}
• {"endpoint_text":"- Ongoing pregnancy: positive heartbeat at ultrasound after 20 weeks of gestation","definition_or_measurement_approach":"Confirmed fetal heartbeat on ultrasound after 20 weeks."}
• {"endpoint_text":"- Gestational age at delivery","definition_or_measurement_approach":"Gestational age recorded at delivery."}
• {"endpoint_text":"- Mode of delivery (vaginal delivery / C-section)","definition_or_measurement_approach":"Recorded mode of delivery: vaginal or cesarean section."}
• {"endpoint_text":"- Incidence of obstetric complications: preterm birth; preeclampsia; placenta previa; small-for-gestational age or growth restriction; large-for-gestational age","definition_or_measurement_approach":"Incidence rates of listed obstetric complications as recorded in follow-up."}
• {"endpoint_text":"- Fetal anomalies: any fetal anomaly (altered system and description of the anomaly), diagnostic of chromosomal or genetic abnormalities (yes/no; if yes, details of the anomaly)","definition_or_measurement_approach":"Recording of any fetal anomaly with system description and chromosomal/genetic diagnostic status."}
• {"endpoint_text":"- Live birth (yes/no)","definition_or_measurement_approach":"Recorded live birth status (yes/no)."}
• {"endpoint_text":"- Local tolerance.","definition_or_measurement_approach":"Assessment of local tolerability (local adverse events) in participants."}
• {"endpoint_text":"- Adverse events.","definition_or_measurement_approach":"Recording and classification of adverse events (local and systemic) in male and female participants."}
• {"endpoint_text":"- Safety laboratory.","definition_or_measurement_approach":"Laboratory safety parameters measured per protocol."}
• {"endpoint_text":"- Vital signs.","definition_or_measurement_approach":"Vital signs monitoring as per schedule."}

Methods

• Instagram story recruitment material (document: K2_Recruitment_material_Instagram_historia) — social media channel targeting potential participants/couples (document title indicates Instagram story).
• Instagram post recruitment material (document: K2_Recruitment_material_Instagram_post) — social media channel targeting potential participants/couples (document title indicates Instagram post).
• Printed leaflet / tr�ptico (document: K2_Recruitment_material_Triptico) — physical leaflet for local distribution.
• Web recruitment material (document: K2_Recruitment_material_WEB_estudio) — website/webpage recruitment information.
• Recruitment arrangements document (K1_Recruitment arrangements) — procedural recruitment arrangements for the study.

Spain

Latest Decision Or Authorization Date

06-03-2026

Number Of Sites

14

Number Of Participants

732

Primary sponsor

Full Name

Prokrea Bcn S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Adknoma Health Research S.L.","duties_or_roles":"1,10,12,5,6,8","organisation_type":"Pharmaceutical company"}