Cetrorelix and Ganirelix Flexible Protocol for (IVF) (IVF)

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

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).

Study Overview

• Status: Unknown
• Conditions: Infertility/Sterility
• Intervention / Treatment: Drug: Ganirelix Acetate; Drug: Cetrorelix Acetate

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antonia Iacovelli, Doctor; Phone Number: 3203595229; Email: antonia.iacovelli.med@gmail.com
• Study Contact Backup: Name: Gian Mario Tiboni, professor; Phone Number: 347 8787545; Email: tiboni@unich.it

Study Locations

• Italy
  • Chieti
    • Ortona, Chieti, Italy, 66026
      • Recruiting
      • Ospedale Bernabeo
      • Contact: Antonia Iacovelli, Doctor; Phone Number: 3203595229; Email: antonia.iacovelli.med@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ganirelix; multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met	Drug: Ganirelix Acetate; multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Experimental: cetrorelix; multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met	Drug: Cetrorelix Acetate; multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Investigators: Study Director: Gian Mario Tiboni, professor, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): January 15, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: In vitro fertilization; gnrh antagonist; pituitary suppression
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Cetrorelix; Ganirelix
• Other Study ID Numbers: Cetrorelix-Ganirelix

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No