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Clinical trial to assess the efficacy and safety of a post-coital intravaginal gel of PKB171 in couples with mild male factor infertility.
EU CTIS ID: 2023-503850-11-00
What this study is testing
Efficacy (Clinical pregnancy defined as intrauterine pregnancy with confirmed heartbeat by the 6th-8th weeks of gestation) up to three treatment cycles of the Gel PKB171 compared to placebo vaginal gel in couples with mild male factor infertility.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent form signed by the participant couple
- 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.
- 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
- 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)
You likely can't join if
- Body mass Index (BMI) < 18 and ≥ 32 kg/m².
- 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 principal investigator.
- Patients with severe coronary artery disease, when in the physician’s judgement myocardial stimulation might prove harmful.
See the full eligibility criteria
Who can join
- Written informed consent form signed by the participant couple
- 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.
- 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
- 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)
What rules you out
- Body mass Index (BMI) < 18 and ≥ 32 kg/m².
- 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 principal investigator.
- 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 (valid results within 4 months before inclusion).
- 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 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
- 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.