Cetrorelix and Ganirelix Flexible Protocol for (IVF)

NCT03477929 — Phase 4, Unknown, 100 participants, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial

Registry	NCT03477929, acronym IVF
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Università degli Studi 'G. d'Annunzio' Chieti e Pescara (Other)
Conditions	Infertility/Sterility
Interventions	Ganirelix Acetate, Cetrorelix Acetate (Drug)
Dates	start 2017-11-15, primary completion 2018-12-15 (estimated), completion 2019-01-15 (estimated), first posted 2018-03-27, last updated 2018-03-27
Locations	1 site in Italy

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
ganirelix	Experimental	Drug: Ganirelix Acetate	multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
cetrorelix	Experimental	Drug: Cetrorelix Acetate	multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met

Ganirelix Acetate (Drug): multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Cetrorelix Acetate (Drug): multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met

+Outcome measures

Primary outcomes

serum LH levels [through study completion,an average of 9 months]: percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.

Secondary outcomes

number of follicles ≥ 14mm on the day of hCG administration [through study completion,an average of 9 months]: number of follicles ≥ 14mm
FSH serum levels on the day of hCG administration [through study completion,an average of 9 months]: mUI/ml
FSH on the day of antagonist administration [through study completion,an average of 9 months]: mUI/ml
FSH serum level on the day after the antagonist administration [through study completion,an average of 9 months]: mUI/ml
LH serum level on the day of antagonist administration [through study completion,an average of 9 months]: mUI/ml
LH serum level on the day after the antagonist administration [through study completion,an average of 9 months]: mUI/ml
E2 serum level on the day of antagonist administration [through study completion,an average of 9 months]: mUI/ml
E2 serum level on the day after the antagonist administration [through study completion,an average of 9 months]: mUI/ml
number of oocyte retrieved [through study completion,an average of 9 months]: how many oocyte were retrieved on transvaginal oocyte retrieval
number of metaphase II oocyte retrieved [through study completion,an average of 9 months]: how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
embryos obtained for patients [72 hours after transvaginal oocyte retrieval]: how many embryos were obtained for patient for each arm
grade A embryos transferred [72 hours after transvaginal oocyte retrieval]: number of grade A embryo were transferred for patient
total dose of gonadotropins administered [through study completion,an average of 9 months]: number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
duration of gonadotropin treatment [through study completion,an average of 9 months]: how many days were necessary to complete the Controlled Ovarian Hyperstimulation
percentage of patients developing OHSS [15 days after the transvaginal oocyte retrieval]: how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
implantation rate [30 days after the embyo transfer]: The number of gestational sacs observed divided by the number of embryos transferred.
pregnancy rate [14 days after the transvaginal oocyte retrieval]: The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred

+Eligibility

Sex: Female, ages: 18 Years to 39 Years, accepts healthy volunteers

Inclusion criteria :

* 18-39 hyears old with regular menstrual cycles (25-35 days in length);
* Body Mass Index between 18-29 kg\\m2
* Basal follicle-stimulating hormone levels within normal range (<30 mUI\\mL)
* Absence of clinically relevant anomalies at transvaginal ultrasound examinatio

Exclusion Criteria:

* Patients affected by grade III or IV endometriosis according to American Society for Reproductive Medicine (ASRM)
* History of Ovarian Hyperstimulation Stimulation (OHSS)
* History of poor response in previous IVF\\ICSI cycle: ≤ 3 oocytes retrieved
* ≥ 3 prior consecutive IVF\\ICSI cycle without a clinical pregnancy.

+Locations (1)

Facility	City	Country	Status
Ospedale Bernabeo	Ortona, Chieti	Italy	Recruiting

+Investigators

Gian Mario Tiboni, professor, Study director, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

My Notes

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