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Trial · NCT03296527

Registered outcomes61

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryCirculating Concentrations of EstradiolOn stimulation Day 6Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.
SecondaryCirculating Concentrations of EstradiolEnd-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.
SecondaryCirculating Concentrations of ProgesteroneOn stimulation Day 6Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.
SecondaryCirculating Concentrations of ProgesteroneEnd-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.
SecondaryCirculating Concentrations of Inhibin AOn stimulation Day 6Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.
SecondaryCirculating Concentrations of Inhibin AEnd-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.
SecondaryCirculating Concentrations of Inhibin BOn stimulation Day 6Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.
SecondaryCirculating Concentrations of Inhibin BEnd-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.
SecondaryCirculating Concentrations of Follicle-stimulating Hormone (FSH)On stimulation Day 6Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.
SecondaryCirculating Concentrations of FSHEnd-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.
SecondaryCirculating Concentrations of FSHAt oocyte retrievalBlood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.
SecondaryTotal Gonadotropin DoseUp to 20 stimulation daysCalculated by start dates, end dates and daily dose of IMP.
SecondaryProportion of Subjects With Investigator-requested Gonadotropin Dose AdjustmentsUp to 20 stimulation daysInvestigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.
SecondaryNumber of Stimulation DaysUp to 20 stimulation daysCalculated by start dates and end dates.
SecondaryNumber of Participants With Adverse EventsFrom screening up to end-of-trial (up to approximately 5.5 months)
Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.
SecondaryIntensity of Adverse EventsFrom screening up to end-of-trial (up to approximately 5.5 months)
The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).
SecondaryChanges From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl TransferaseFrom screening up to end-of-trial (up to approximately 5.5 months)Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.
SecondaryChange From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and SodiumFrom screening up to end-of-trial (approximately 5.5 months)Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.
SecondaryChange From Baseline in Clinical Chemistry Parameters: Albumin and ProteinFrom screening up to end-of-trial (approximately 5.5 months)Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.
SecondaryChange From Baseline in Clinical Chemistry Parameter: Lactate DehydrogenaseFrom screening up to end-of-trial (approximately 5.5 months)Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.

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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