Trial · NCT03228680
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 39 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | The median and IQR of FSH and LH levels at end-of-stimulation are presented. |
| Secondary | Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6 | At Day 6 of stimulation | The median and IQR of estradiol levels on stimulation Day 6 are presented. |
| Secondary | Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | The median and IQR of estradiol levels at end-of-stimulation are presented. |
| Secondary | Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6 | At Day 6 of stimulation | The median and IQR of progesterone levels on stimulation Day 6 are presented. |
| Secondary | Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | The median and IQR of progesterone levels at end-of-stimulation are presented. |
| Secondary | Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6 | At Day 6 of stimulation | The median and IQR of Inhibin A levels on stimulation Day 6 are presented. |
| Secondary | Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | The median and IQR of Inhibin A levels at end-of-stimulation are presented. |
| Secondary | Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6 | At Day 6 of stimulation | The median and IQR of inhibin B levels on stimulation Day 6 are presented. |
| Secondary | Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | The median and IQR of inhibin B levels at end-of-stimulation are presented. |
| Secondary | Number of Stimulation Days | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Total Gonadotropin Dose of FE 999049 | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Total Gonadotropin Dose of FOLLISTIM | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Number of Participants With Adverse Events (AEs) Stratified by Intensity | From signed informed consent up to 5-6 weeks after transfer | The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE 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 Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid. |
| Secondary | Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets. |
| Secondary | Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial | Up to 5-6 weeks after transfer | Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid. |
| Secondary | Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial | Up to 5-6 weeks after transfer | Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets. |
| Secondary | Frequency and Intensity of Injection Site Reactions | End-of-stimulation (up to 20 stimulation days) | The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented. |
| Secondary | Technical Malfunctions of the Administration Pens | End-of-stimulation (up to 20 stimulation days) |
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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