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New treatment option for Infertility Due to Azoospermia
Official title PKB171 Against Placebo in Couples With Mild Male Factor Infertility
ClinicalTrials.gov ID: NCT07669584
What this study is testing
What is Intravaginal gel?
Intravaginal gel is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for infertility due to azoospermia.
Also referred to as PKB171 200 mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The test medication Gel PKB171 is a vaginal gel that has not yet been licensed by the regulatory authorities. However, the active substance pentoxifylline has been available as tablets for decades and is used to increase peripheral blood flow in patients with circulation problems.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 38
You may be able to join if
- people eligible for inclusion in this study must meet all the following criteria:
- Written informed consent form signed before any study test or procedure.
- Unable to conceive for more than 6 months and less than 24 months, despite regular and adequate unprotected sexual intercourse.
- Willing and able to comply with the protocol.
- Female people with the following criteria:
You likely can't join if
- people eligible for this study, both women and men, must not meet any of the following criteria:
- Body mass Index (BMI) \< 18 and ≥ 32 kg/m².
- Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks entry in the study and during it.
- Couples who had any previous assisted reproductive technology (ART) cycle (in vitro fertilization, IVF, or intracytoplasmic sperm injection, ICSI)...
- Active hepatitis B, C, HIV, genital herpes, Chlamydia, Gonorrhea or Syphilis infection.
- History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
See the full eligibility criteria
- people eligible for inclusion in this study must meet all the following criteria:
- Written informed consent form signed before any study test or procedure.
- Unable to conceive for more than 6 months and less than 24 months, despite regular and adequate unprotected sexual intercourse.
- Willing and able to comply with the protocol.
- Female people 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 the first visit.
- Normal uterine cavity shown on transvaginal sonography.
- Normal ovarian reserve, demonstrated by AMH ≥ 1 ng/ml at day 2-5 of the cycle.
- Antral follicle count (sum of both ovaries) ≥ 6
- Male people 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%
- people eligible for this study, both women and men, must not meet any of the following criteria:
- Body mass Index (BMI) \< 18 and ≥ 32 kg/m².
- Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks entry in the study and during it.
- Couples who had any previous assisted reproductive technology (ART) cycle (in vitro fertilization, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial.
- Active hepatitis B, C, HIV, genital herpes, Chlamydia, Gonorrhea or Syphilis infection.
- History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
- History of cerebral or retinal hemorrhage, acute myocardial infarction.
- In females: Prohibited concomitant intravaginal products or procedures.
- Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP.
- 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...
- People committed to an institution by virtue of an order issued either by the judicial or other authorities.
- 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.
- Patients with peptic ulcers or recent history thereof.
- Patients with haemorrhage (e.g. extensive retinal bleeding) or at risk of increased bleeding
- Patients with severe coronary artery disease, when in the physician's judgement myocardial stimulation might prove harmful.
- Patients with severe hepatic and renal impairment.
- Patients without adequate laboratory parameters according to the normal ranges of local laboratory.
- 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...
- 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 pentoxifylline.
- Two or more clinical or preclinical spontaneous miscarriages.
- Lactation or pregnancy.
- Known abnormal karyotype
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Seville, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 38 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pamplona, Navarre, Spain; Barcelona, Spain; Madrid, Spain; Seville, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.