Trial · NCT03296527
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
41 to 60 of 61
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate. |
| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate | End-of-stimulation visit and end-of-trial visit | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate. |
| Secondary | Change From Baseline in Haematology Parameter: Erythrocytes | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Erythrocytes. |
| Secondary | Change From Baseline in Haematology Parameters: Leukocytes and Platelets | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets. |
| Secondary | Change From Baseline in Haematology Parameter: Haemoglobin | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Haemoglobin. |
| Secondary | Change From Baseline in Haematology Parameter: Haematocrit | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Haematocrit. |
| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume. |
| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin. |
| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration. |
| Secondary | Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes | From screening up to end-of-trial (approximately 5.5 months) | Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes. |
| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes | End-of-stimulation visit and end-of-trial visit | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes. |
| Secondary | Number of Immune-related Adverse Events | From screening up to end-of-trial (approximately 5.5 months) | Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs). |
| Secondary | Frequency of Injection Site Reactions | End-of-stimulation (up to 20 stimulation days) | Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection. |
| Secondary | Intensity of Injection Site Reactions | End-of-stimulation (up to 20 stimulation days) | Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions. |
| Secondary | Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity | Up to 28 days after end of the stimulation period | Measured by presence of anti-FSH antibodies. |
| Secondary | Intensity of Immune-related Adverse Events | From screening up to end-of-trial (approximately 5.5 months) | The intensity of immune-related 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). |
| Secondary | Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen | Up to 20 stimulation days | For each participant the reason for cycle cancellation will be recorded. |
| Secondary | Proportion of Subjects With Late OHSS | After 9 days post triggering of final follicular maturation | Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe. |
| Secondary | Proportion of Participants With Multi-fetal Gestation | End-of-trial | Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented. |
| Secondary | Proportion of Participants With Early Pregnancy Losses | End-of-trial | Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention). Frequency of early pregnancy losses are presented. |
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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