Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Infertility/Sterility Clinical Trial

— IVF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477929
• Other study ID #: Cetrorelix-Ganirelix
• Status: Recruiting
• Phase: Phase 4
• First received: February 28, 2018
• Last updated: March 19, 2018
• Start date: November 15, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: March 2018
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: Gian Mario Tiboni, professor
• Phone: 347 8787545
• Email: tiboni[@]unich.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility/Sterility

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Bernabeo	Ortona	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

Outcome

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