A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of a post-coital intravaginal gel of PKB171 in couples with mild male factor infertility.

Conditions

Oligospermia and/or asthenozoospermia

Brief summary

Rate of clinical pregnancies defined as intrauterine pregnancy with confirmed fetal heartbeat by the 6-8th week of gestation.

Detailed description

Rate of Biochemical pregnancy: positive pregnancy test (blood β-hCG), Rate of Pregnancy loss: nonviable intrauterine pregnancy up to 20 weeks gestation, Ongoing pregnancy: positive heartbeat at ultrasound after 20 weeks of gestation, Gestational age at delivery, Mode of delivery (vaginal delivery / C-section), Incidence of obstetric complications: preterm birth; preeclampsia; placenta previa; small-for-gestational age or growth restriction; large-for-gestational age, 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), Live birth (yes/no), Local tolerance., Adverse events., Safety laboratory., Vital signs.

Related papers

No related papers found yet.

Interventions

DRUGGel PKB171

DRUGPlacebo gel XXX

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Rate of clinical pregnancies defined as intrauterine pregnancy with confirmed fetal heartbeat by the 6-8th week of gestation.	—

Secondary

Measure	Time frame
Rate of Biochemical pregnancy: positive pregnancy test (blood β-hCG), Rate of Pregnancy loss: nonviable intrauterine pregnancy up to 20 weeks gestation, Ongoing pregnancy: positive heartbeat at ultrasound after 20 weeks of gestation, Gestational age at delivery, Mode of delivery (vaginal delivery / C-section), Incidence of obstetric complications: preterm birth; preeclampsia; placenta previa; small-for-gestational age or growth restriction; large-for-gestational age, 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), Live birth (yes/no), Local tolerance., Adverse events., Safety laboratory., Vital signs.	—

Measure

Time frame

Rate of Biochemical pregnancy: positive pregnancy test (blood β-hCG), Rate of Pregnancy loss: nonviable intrauterine pregnancy up to 20 weeks gestation, Ongoing pregnancy: positive heartbeat at ultrasound after 20 weeks of gestation, Gestational age at delivery, Mode of delivery (vaginal delivery / C-section), Incidence of obstetric complications: preterm birth; preeclampsia; placenta previa; small-for-gestational age or growth restriction; large-for-gestational age, 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), Live birth (yes/no), Local tolerance., Adverse events., Safety laboratory., Vital signs.

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Countries

Spain

Outcome results

None listed