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Trial · NCT01857310

Outcomes38

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYMajor Neonatal ComplicationsDeliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYStructural MalformationsDeliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSevere Maternal MorbidityDeliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFertilization Rate Per Cycle, %Up to 9 months of fertility treatment post-randomization124 and 135 participants randomized to active and placebo arms, respectively Fertilization rate unavailable in medical records for 17 and 28 participants in the active and placebo arms, respectivelypercent per cycleMEAN
SECONDARYNumber of Good Quality Embryos on Day 5 Per CycleUp to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Day 5 good quality embryos unavailable in medical records for 56 and 64 participants in the active and placebo arms, respectively
embryos per cycleMEAN
SECONDARYPercentage of Good Quality Embryos on Day 5 Per CycleUp to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Proportion day 5 good quality embryos unavailable in medical records for 17 and 28 participants in the active and placebo arms, respectively
percent per cycleMEAN
SECONDARYNumber of Embryos Transferred Per CycleUp to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Proportion day 5 good quality embryos unavailable in medical records for 7 and 9 participants in the active and placebo arms, respectively
embryos per cycleMEAN
SECONDARYNumber of Embryos Cryopreserved Per CycleUp to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Number of embryos cryopreserved unavailable in medical records for 40 and 35 participants in the active and placebo arms, respectively
embryos per cycleMEAN
SECONDARYSperm Penetration Per Cycle, %Up to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Sperm penetration \& unavailable in medical records for 114 and 121 participants in the active and placebo arms, respectively
percent penetrationMEAN
SECONDARYCells on Day 3 Per Embryo Per CycleUp to 9 months of fertility treatment post-randomization
1215 embryos among cycles among women in the FA/Zn arm; 1129 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively~\# of cells on day 3 unavailable in medical records for 25 and 36 participants in the active and placebo arms, respectively
cells per embryoMEAN
SECONDARYCells on Day 3 Per Embryo Per Cycle, CategoricalUp to 9 months of fertility treatment post-randomization
1222 embryos among cycles among women in the FA/Zn arm; 1140 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively~\# of cells on day 3 (categorical) unavailable in medical records for 25 and 36 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYCells on Day 5 Per Embryo Per Cycle, CategoricalUp to 9 months of fertility treatment post-randomization
1160 embryos among cycles among women in the FA/Zn arm and 1205 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively~\# of cells on day 5 (categorical) unavailable in medical records for 5 and 14 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYEmbryo Morphology on Day 3 Per Cycle, CategoricalUp to 9 months of fertility treatment post-randomization
961 embryos among cycles among women in the FA/Zn arm; 931 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively Embryo morphology on day 3 (categorical) unavailable in medical records for 27 and 37 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYEmbryo Morphology on Day 5 Per Cycle, CategoricalUp to 9 months of fertility treatment post-randomization
973 embryos among cycles among women in the FA/Zn arm; 1009 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively Embryo morphology on day 5 (categorical) unavailable in medical records for 10 and 19 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYMethod of Fertilization Per CycleUp to 9 months of fertility treatment post-randomization
1689 embryos among cycles among women in the active treatment arm; 1800 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively Method of fertilization unavailable in medical records for 2 and 5 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYQuality of Embryos Transferred Per Cycle, CategoricalUp to 9 months of fertility treatment post-randomization
172 embryos among cycles among women in the FA/Zn arm; 187 embryos among cycles among women in the placebo arm 124 and 135 participants randomized to active and placebo arms, respectively Quality of embryos transferred (categorical) unavailable in medical records for 21 and 30 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
SECONDARYChromosomal Complement of Embryo Per CycleUp to 9 months of fertility treatment post-randomization
124 and 135 participants randomized to active and placebo arms, respectively Chromosomal complement of embryo unavailable in medical records for 121 and 124 participants in the active and placebo arms, respectively
predicted probabilityNUMBER
OTHER_PRE_SPECIFIEDReproductive Hormones and Other Measured Biomarkers4 or 6 months

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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