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Trial · NCT03088137

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryOocytes (Intention-to-Treat, ITT)From date of randomization up to 18 days
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
SecondaryNumber of Follicles With Size ≥ 16 mmFrom date of randomization up to 16 daysThe number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
SecondaryMature OocytesFrom date of randomization up to 18 daysThe number of mature oocytes (MII stage of development)
SecondaryFertilised OocytesFrom date of randomization up to 19 daysThe number of fertilised oocytes with the presence of two pronuclei: 2PN
SecondaryPercentage of Patients With Embryo TransferFrom date of randomization up to 25 daysThe number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
SecondaryTotal Dose of Follitropin AlfaFrom date of randomization up to 16 daysThe total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
SecondaryNumber of Days of Follitropin Alfa TreatmentFrom date of randomization up to 16 daysThe duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
SecondaryNumber of Patients With Follitropin Alfa Dose CorrectionFrom date of randomization up to 16 daysThe number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
SecondaryNumber of Patients With Cycle CancellationFrom date of randomization up to 16 daysThe number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
SecondaryNumber of No-respondersFrom date of randomization up to 8 daysThe number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)
SecondaryPercentage of Patients With Serum hCG More Than 25 IU/lFrom date of randomization up to 42 daysBiochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
SecondaryPercentage of Patients With the Evidence for Clinical PregnancyThe 10th week after embryo transferConfirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity

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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