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Trial · NCT05266924

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryNumber of oocytes retrievedOocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administrationNumber of oocytes retrieved
SecondaryClinical pregnancy rate4 weeks after embryo transfer (ET)Clinical pregnancy rate
SecondaryOngoing Pregnancy rate11±1 weeks after ETOngoing pregnancy rate
SecondaryCycle cancellation rateat Stimulation phase up to 20 days, oocyte pick up up to ~ 34 to 36 hours after hCG administration, ET anytime up to 8 weeksCycle cancellation rate
SecondaryTotal Doseof r-hFSHat end of stimulation up to 20 daysTotal dose of r-hFSH (in IU) required for ovarian stimulation;
SecondaryNumber of Days of r-hFSH stimulationat end of stimulation up to 20 daysNumber of days of r-hFSH stimulation
SecondaryNumber of subject Change in Dosagepost Day 6 till end of stimulation up to 20 daysProportion of subjects requiring change in dose
SecondaryHormonal InvestigationDay 6Estradiol, Luteinizing, Progesterone, and inhibin b levels
SecondaryFollicle size on Day 6Day 6
Number of follicles with size \<11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm
SecondaryFollicle size at HCG administrationDay of hCG administration anytime upto 3 weeks
Number of follicles with size \<11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm mm)
SecondaryEndometrium thicknessday 6Endometrial thickness (mm)
SecondaryEndometrium at HCG administrationday of hCG injection (anytime upto 3 weeks)Endometrial thickness (mm)
SecondaryNumber of Matured oocytesOocyte pick up ~ 34 to 36 hours after hCG administrationProportion of matured oocytes
SecondaryNumber of good quality embryosET day (up to 8 weeks)Number of good quality embryos
SecondaryNumber of Adverse events
Baseline, 1st day of stimulation, day 6 , end of stimulation up to 20 days, hCG administration, oocyte pick up ~ 34 to 36 hours after hCG administration, ET up to 8 weeks, clinical pregnancy (after 4 weeks of ET), ~12 weeks after ET
Number of treatment-emergent adverse events (TEAE) reported
SecondarySpecific adverse eventsDay 1 of Stimulation till ~12 weeks after ETThe number of patients with ovarian hyperstimulation syndrome (OHSS) reported
SecondaryExploratoryEnd of stimulation up to 20 daysEase of use of Pen - comparison of total score of Questionnaire to user of rhFSH pen
SecondaryEvaluation of immunogenicity (antibody) of r-hFSHBaseline, 4 weeks and 12 weeksEvaluation of immunogenicity of r-hFSH, comparison of antibody titre against r-hFSH in both groups

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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