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Trial · NCT04616729

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimarySafety profile with regard to the risk of OHSS: assessment of change in ovarian volumeDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A transvaginal ultrasound will be performed to measure the ovarian volume according to the formula 'length x width x height x 0.523' mm³. In the assumption of safety ovarian volume should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in hematocritDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate hematocrit (%). In the assumption of safety hematocrit levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in hemoglobineDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate hemoglobine (g/dL). In the assumption of safety hemoglobine levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in White Blood cell CountDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate White Blood cell Count (X10³/mm³). In the assumption of safety White Blood cell Count should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in Platelet CountDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate Platelet Count (X10³/mm³). In the assumption of safety Platelet Count should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in estimated glomerular filtration rate (eGFR)During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate eGFR (mL/min/1.73m²). In the assumption of safety eGFR levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in CreatinineDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate Creatinine (mg/dL). In the assumption of safety creatinine levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in AlbuminDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate Albumin (g/L). In the assumption of safety Albumin levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in liver function (AST, ALT, Gamma-GT, bilirubine, LDH)During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate liver function (AST U/L, ALT U/L, Gamma-GT U/L, bilirubine mg/dL, LDH U/L). In the assumption of safety liver function levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in Oestradiol (E2)During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate Oestradiol (ng/L). In the assumption of safety Oestradiol levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in ProgesteronDuring one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate Progesteron (mcg/L). In the assumption of safety Progesteron levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in Follicle Stimulating Hormone (FSH)During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate FSH (IU/L). In the assumption of safety FSH levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
PrimarySafety profile with regard to the risk of OHSS: assessment of change in Luteinizing Hormone (LH)During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
A blood sample will be taken to evaluate LH (IU/L). In the assumption of safety LH levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
SecondaryNumber of cumulus-oocyte complexesDuring the procedure of the transvaginal oocyte retrievalEvaluation of the number of cumulus-oocyte complexes between the Depot Group and Daily Group
SecondaryNumber of Metaphase II oocytesImmediately after the procedure of the transvaginal oocyte retrievalEvaluation of the number of Metaphase II oocytes between the Depot group and Daily group
SecondaryEvaluation of climacteric symptomsOne week after the transvaginal oocyte retrieval (on day 7)Assessment of MENQOL (The Menopause-Specific Quality of Life) Questionnaire

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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