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

March 19, 2018 updated by: Antonia Iacovelli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gian Mario Tiboni, professor
  • Phone Number: 347 8787545
  • Email: tiboni@unich.it

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 35 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum LH levels
Time Frame: 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.
through study completion,an average of 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of follicles ≥ 14mm on the day of hCG administration
Time Frame: through study completion,an average of 9 months
number of follicles ≥ 14mm
through study completion,an average of 9 months
FSH serum levels on the day of hCG administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
FSH on the day of antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
FSH serum level on the day after the antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
LH serum level on the day of antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
LH serum level on the day after the antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
E2 serum level on the day of antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
E2 serum level on the day after the antagonist administration
Time Frame: through study completion,an average of 9 months
mUI/ml
through study completion,an average of 9 months
number of oocyte retrieved
Time Frame: through study completion,an average of 9 months
how many oocyte were retrieved on transvaginal oocyte retrieval
through study completion,an average of 9 months
number of metaphase II oocyte retrieved
Time Frame: through study completion,an average of 9 months
how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
through study completion,an average of 9 months
embryos obtained for patients
Time Frame: 72 hours after transvaginal oocyte retrieval
how many embryos were obtained for patient for each arm
72 hours after transvaginal oocyte retrieval
grade A embryos transferred
Time Frame: 72 hours after transvaginal oocyte retrieval
number of grade A embryo were transferred for patient
72 hours after transvaginal oocyte retrieval
total dose of gonadotropins administered
Time Frame: through study completion,an average of 9 months
number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
through study completion,an average of 9 months
duration of gonadotropin treatment
Time Frame: through study completion,an average of 9 months
how many days were necessary to complete the Controlled Ovarian Hyperstimulation
through study completion,an average of 9 months
percentage of patients developing OHSS
Time Frame: 15 days after the transvaginal oocyte retrieval
how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
15 days after the transvaginal oocyte retrieval
implantation rate
Time Frame: 30 days after the embyo transfer
The number of gestational sacs observed divided by the number of embryos transferred.
30 days after the embyo transfer
pregnancy rate
Time Frame: 14 days after the transvaginal oocyte retrieval
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gian Mario Tiboni, professor, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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