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

Primary Purpose

Infertility/Sterility

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ganirelix Acetate
Cetrorelix Acetate
Sponsored by
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility/Sterility focused on measuring In vitro fertilization, gnrh antagonist, pituitary suppression

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Ospedale BernabeoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ganirelix

cetrorelix

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2018
Last Updated
March 19, 2018
Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
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1. Study Identification

Unique Protocol Identification Number
NCT03477929
Brief Title
Cetrorelix and Ganirelix Flexible Protocol for (IVF)
Acronym
IVF
Official Title
Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
January 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility/Sterility
Keywords
In vitro fertilization, gnrh antagonist, pituitary suppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ganirelix
Arm Type
Experimental
Arm Description
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Arm Title
cetrorelix
Arm Type
Experimental
Arm Description
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Intervention Type
Drug
Intervention Name(s)
Ganirelix Acetate
Intervention Description
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Intervention Type
Drug
Intervention Name(s)
Cetrorelix Acetate
Intervention Description
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Primary Outcome Measure Information:
Title
serum LH levels
Description
percentage of patients not having serum levels of LH ≥ 10IU\L (defined as premature LH surge) on the day of hCG administration.
Time Frame
through study completion,an average of 9 months
Secondary Outcome Measure Information:
Title
number of follicles ≥ 14mm on the day of hCG administration
Description
number of follicles ≥ 14mm
Time Frame
through study completion,an average of 9 months
Title
FSH serum levels on the day of hCG administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
FSH on the day of antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
FSH serum level on the day after the antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
LH serum level on the day of antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
LH serum level on the day after the antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
E2 serum level on the day of antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
E2 serum level on the day after the antagonist administration
Description
mUI/ml
Time Frame
through study completion,an average of 9 months
Title
number of oocyte retrieved
Description
how many oocyte were retrieved on transvaginal oocyte retrieval
Time Frame
through study completion,an average of 9 months
Title
number of metaphase II oocyte retrieved
Description
how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
Time Frame
through study completion,an average of 9 months
Title
embryos obtained for patients
Description
how many embryos were obtained for patient for each arm
Time Frame
72 hours after transvaginal oocyte retrieval
Title
grade A embryos transferred
Description
number of grade A embryo were transferred for patient
Time Frame
72 hours after transvaginal oocyte retrieval
Title
total dose of gonadotropins administered
Description
number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
Time Frame
through study completion,an average of 9 months
Title
duration of gonadotropin treatment
Description
how many days were necessary to complete the Controlled Ovarian Hyperstimulation
Time Frame
through study completion,an average of 9 months
Title
percentage of patients developing OHSS
Description
how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
Time Frame
15 days after the transvaginal oocyte retrieval
Title
implantation rate
Description
The number of gestational sacs observed divided by the number of embryos transferred.
Time Frame
30 days after the embyo transfer
Title
pregnancy rate
Description
The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred
Time Frame
14 days after the transvaginal oocyte retrieval

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gian Mario Tiboni, professor
Phone
347 8787545
Email
tiboni@unich.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Iacovelli, doctor
Phone
3203595229
Email
antonia.iacovelli.med@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gian Mario Tiboni, professor
Organizational Affiliation
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Bernabeo
City
Ortona
State/Province
Chieti
ZIP/Postal Code
66026
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Iacovelli, Doctor
Phone
3203595229
Email
antonia.iacovelli.med@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cetrorelix and Ganirelix Flexible Protocol for (IVF)

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