Trial · NCT01857310
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Live Birth | At delivery | Complete randomized cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Semen Volume | 6 months | Analyzed overall and by fertility treatment stratum (subgroup) 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. | mL | MEAN |
| PRIMARY | Sperm Concentration | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, one male participant in the placebo arm had insufficient quantity or quality to assess concentration. | 10^6 spermatozoa/mL | MEAN |
| PRIMARY | Sperm Motility | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, one male participant in the placebo arm had insufficient quantity or quality to assess motility. | % motile | MEAN |
| PRIMARY | Sperm Morphology | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 19 men in the active arm and 17 men in the placebo arm had insufficient quantity or quality to assess morphology. | % normal | MEAN |
| PRIMARY | DNA Fragmentation Index | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 44 men in the active arm and 55 men in the placebo arm had insufficient quantity or quality to assess DFI. | % breakage | MEAN |
| PRIMARY | Total Motile Sperm Count | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 1 man in the active arm and 2 men in the placebo arm had insufficient quantity or quality to assess total motile count. | million motile sperm | MEAN |
| SECONDARY | Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation) | For IVF, 12 days post embryo transfer for day 5 embryo transfers, and 14 days post embryo transfer for day 3 embryo transfers; for couples undergoing OI/IUI, after self-report of positive pregnancy test | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Intrauterine Pregnancy | approximately 6.5 weeks gestation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ectopic Pregnancy | approximately 6.5 weeks gestation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Early Pregnancy Loss | hcG-detected pregnancy until 20 weeks of pregnancy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preeclampsia or Gestational Hypertension | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Gestational Diabetes | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cesarean Delivery | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preterm Delivery | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Small for Gestational Age | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Gestational Age | Delivery | Among participants with live birth | weeks | MEAN |
| SECONDARY | Birth Weight | Delivery | Among participants with live birth | grams | MEAN |
| SECONDARY | Stillbirth | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neonatal Mortality | Delivery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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