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Trial · NCT03296527

Outcomes61

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

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYChange From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, UrateFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.umol/LMEAN
SECONDARYProportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, PhosphateEnd-of-stimulation visit and end-of-trial visitThe safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.percentage of participantsNUMBER
SECONDARYChange From Baseline in Haematology Parameter: ErythrocytesFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.10^12 cells/LMEAN
SECONDARYChange From Baseline in Haematology Parameters: Leukocytes and PlateletsFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.10^9 cells/LMEAN
SECONDARYChange From Baseline in Haematology Parameter: HaemoglobinFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.g/LMEAN
SECONDARYChange From Baseline in Haematology Parameter: HaematocritFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.RatioMEAN
SECONDARYChange From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular VolumeFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.FemtolitersMEAN
SECONDARYChange From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular HaemoglobinFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.picogramMEAN
SECONDARYChange From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin ConcentrationFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.mmol/LMEAN
SECONDARYChange From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/LeukocytesFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.percentageMEAN
SECONDARYProportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/LeukocytesEnd-of-stimulation visit and end-of-trial visitThe safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.percentage of participantsNUMBER
SECONDARYNumber of Immune-related Adverse EventsFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.eventsNUMBER
SECONDARYFrequency of Injection Site ReactionsEnd-of-stimulation (up to 20 stimulation days)The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.percentage of participantsNUMBER
SECONDARYIntensity of Injection Site ReactionsEnd-of-stimulation (up to 20 stimulation days)The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.percentage of participantsNUMBER
SECONDARYProportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing CapacityUp to 28 days after end of the stimulation periodThe safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.percentage of participantsNUMBER
SECONDARYIntensity of Immune-related Adverse EventsFrom screening up to end-of-trial (approximately 5.5 months)The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.eventsNUMBER
SECONDARYProportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration PenUp to 20 stimulation daysThe FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.percentage of participantsNUMBER
SECONDARYProportion of Subjects With Late OHSSAfter 9 days post triggering of final follicular maturationThe safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.percentage of participantsNUMBER
SECONDARYProportion of Participants With Multi-fetal GestationEnd-of-trialThe FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.percentage of participantsNUMBER
SECONDARYProportion of Participants With Early Pregnancy LossesEnd-of-trialThe safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.percentage of participantsNUMBER

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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