Clinical study to investigate the effectiveness and safety of PKB171 in couples with infertility due to reduced sperm mobility who wish to conceive.
- Conditions
- AsthenozoospermiaTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2016-003993-42-ES
- Lead Sponsor
- Prokrea BCN S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion criteria for the couple (i. e. must be fulfilled by male and female):
1.Unable to conceive for at least 12 months, despite regular and adequate unprotected sexual intercourse.
2.Willing and able to comply with the protocol.
Inclusion criteria for male subjects:
3.Male subjects aged 18-50 years.
4.Two semen analyses (at VS2 and VS3), both with the following results:
a.Total number of spermatozoa at least 12 000 000 per ejaculation.
b.Progressive motility less than 32%.
c.Total (progressive and non-progressive) motility less than 40%.
d.Normal forms at least 4%.
e.Viable spermatozoa at least 45%.
Inclusion criteria for female subjects:
5.Female subjects aged 18-35 years.
6.Body mass index (BMI) = 18 and = 30 kg/m².
7.Regular spontaneous menstrual cycles between 21 and 35 days in length (intercycle variations not more than ±5 days) within the last six cycles before visit VS1.
8.Presence of both ovaries.
9.Normal uterine cavity as assessed by transvaginal sonography at VS2. No submucosal fibroids or intramural fibroids exceeding 4 cm in diameter.
10.Normal findings at hysterosalpingography. If results from within the last 24 months are available, the examination will not be repeated at VS2.
11.Hormone blood test at VS2 with the following results:
a.Serum follicle-stimulating hormone (FSH) concentration = 12 IU/L.
b.LH concentration = 7 IU/L.
c.Estradiol (E2) concentration 25-75 pg/mL.
d.Prolactin < 24 ng/mL.
e.Progesterone (P4) < 1.5 ng/mL.
f.Anti-Müllerian hormone (AMH) 2.0-6.8 ng/mL
12.Antral follicle count (sum of both ovaries) = 7 and = 20 measured at VS2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria for the couple (i. e. must not be fulfilled by any part of the couple):
1.Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks before VS1 and willing to continue until VT3.
2.Couples who had more than two unsuccessful previous assisted reproductive technology (ART) cycles (in vitro fertilisation, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial, where unsuccessful is defined as no embryo transfer or no pregnancy was achieved. Former ART cycles, which resulted in live birth do not count.
3.Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP.
4.Heavy consumer of stimulating drinks (more than five cups of coffee, tea, chocolate or cola drinks per day, or more than one can [250 mL] of energy drink per day). Daily consumption of more than 24 g alcohol per day. Smoker with more than five cigarettes per day, including portions of smokeless tobacco, nicotine patches and electronic cigarettes.
5.Any active substance abuse of drugs, medications or alcohol within the last five years.
6.Prohibited concomitant therapies within 28 days before visit VS1 until last treatment visit:
a.Any preparations with sex hormones or modulators of the genital system.
b.Selective estrogen receptor modulators (SERMs), such as tamoxifen or clomifene.
c.Aromatase inhibitors.
d.Oral pentoxifylline.
e.Non-medical practitioners consultations in regards to fertility.
7.Change in intake regimen of the following therapies within 14 days before visit VS1 until last treatment visit:
a.Herbal supplements, such as ginseng, maca or yohimbe.
b.Dietary supplements, such as vitamines, selenium, zinc, carnitine, folic acid or coenzyme Q.
8.Infection with human immunodeficiency virus (HIV), hepatitis B or C, genital herpes, chlamydia, gonorrhoea or syphilis.
9.History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
10.History of cerebral or retinal haemorrhage, acute myocardial infarction, severe cardiac arrhythmia or severe hepatic impairment.
11.Family history of genetic risk factors concerning pregnancy or birth. Known abnormal karyotype.
12.Any other condition of the subject that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardise subject’s safety, compliance or adherence to protocol requirements.
13.Previous enrolment in this trial, or participation in any other clinical trial within the past 30 days prior to enrolment.
14.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.
15.Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
Exclusion criteria for males:
16.Varicocele, as confirmed by physical and ultrasound examination. If varicocele is not suspected or results from within the last 12 months are available, the examination will not be performed at VS2.
Exclusion criteria for females:
17.History of anovulation. History of or known current poly-cystic ovary syndrome (PCOS), endometriosis type III or IV according to the American Society for Reproductive Medicine (ASRM) criteria, or fallopian tube obstruction.
18.Previous gynaecological surgery. One Caesarian section more than
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy (as assessed by rate of clinical pregnancies with fetal heart beat) of up to three treatment cycles with PKB171 vaginal gel compared to placebo vaginal gel in couples with asthenozoospermia.;Secondary Objective: Efficacy, local tolerance and safety of up to three treatment cycles with PKB171 vaginal gel compared to placebo vaginal gel in couples with asthenozoospermia.;Primary end point(s): Rate of clinical pregnancies with fetal heart beat as assessed by TVUS at VP1.;Timepoint(s) of evaluation of this end point: Once last subject last VP1 occurs and data base is locked.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Live birth* rate<br><br>* Live birth refers to the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life - e.g. beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles - whether or not the umbilical cord has been cut or the placenta is attached. Each product of such a birth is considered live born. (WHO definition) <br>2.Pregnancy outcome: gestational age<br>3.Pregnancy outcome: mode of delivery<br>4.Rate of biochemical pregnancies, as assessed by ß-hCG pregnancy test at VP1<br>5.Rate of miscarriages<br>6.Rate of induced abortions<br>7.Rate of ectopic pregnancies at VP1<br>8.Rate of multiple pregnancies at VP1;Timepoint(s) of evaluation of this end point: Once last subject last visit VP2 occurs and data base is locked.