Cetrorelix and Ganirelix Flexible Protocol for (IVF)
IVF
IVF
Sponsor study identifier
interventional
100
1 country
1
Study Start
November 15, 2017
Actual (reported)Primary Completion
December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 15, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recombinant gonadotropins are currently used for ovarian stimulation in women undergoing to IVF for infertility. Recently new flexible protocols have been introduced: the "single dose" and "multiple dose" protocol. The single dose protocol is performed just using Cetrorelix by the administration of a single injection of Cetrorelix 3 mg subcutaneous when the lead follicle is ≥ 14 mm. The multiple dose protocol consider the daily administration of Cetrorelix 0.25 mg subcutaneous or Ganirelix 0.25 mg subcutaneous when the lead follicle is ≥ 14 mm and until the realization of hCG criteriaThere are few data from letterature about the comparison of the efficacy in pitituary suppression and pregnancy outcome of Ganirelix and Cetrorelix. Objective: to compare the efficacy in pituitary gonadotropin suppression and IVF outcome of multiple dose flexible gonadotrophin-releasing hormone (GnRH) antagonist administration according to follicular size using daily injection of Cetrorelix or Ganirelix. Interventions : patients are randomly assigned in to Cetrorelix acetate group or Ganirelix acetate group. Multiple dose of Cetrorelix acetate (0.25 mg) or multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met.Oocyte maturation trigger is performed by the administration of subcutaneous r-hCG (250 μg) or of intramuscular hCG (10,000 IU). After 36 hour transvaginal oocyte retrieval is performed followed by ICSI and embrio transfer (72 hours later).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2017
Actual (reported)February 28, 2018
Actual (reported)March 27, 2018
Actual (reported)December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 15, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
serum LH levels
percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.
through study completion,an average of 9 months
number of follicles ≥ 14mm on the day of hCG administration
through study completion,an average of 9 months
FSH serum levels on the day of hCG administration
through study completion,an average of 9 months
FSH on the day of antagonist administration
through study completion,an average of 9 months
FSH serum level on the day after the antagonist administration
through study completion,an average of 9 months
LH serum level on the day of antagonist administration
through study completion,an average of 9 months
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Ospedale Bernabeo
Ortona, Chieti, 66026, Italy
Gian Mario Tiboni, professor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
First Submitted
February 28, 2018
First Posted
March 27, 2018
Study Start
November 15, 2017
Actual (reported)Primary Completion
December 15, 2018
Estimated (date passed)Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 15, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 27, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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