Infertility/SterilityPhase 4IVFNCT03477929
Cetrorelix and Ganirelix Flexible Protocol for (IVF)
A Phase 4 study testing Ganirelix Acetate and Cetrorelix Acetate in people with Infertility/Sterility, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility/Sterility
- What is being tested?
- Ganirelix Acetate and Cetrorelix Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2017to 15 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Bernabeo
Ortona, Chieti, 66026
Antonia Iacovelli, Doctor, 3203595229, antonia.iacovelli.med@gmail.com
About this study
Official title: 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).
- Conditions
- Infertility/Sterility
- Being tested
- Ganirelix Acetate, Cetrorelix Acetate
- Keywords
- In vitro fertilization, gnrh antagonist, pituitary suppression
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganirelix AcetateDrug
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Cetrorelix AcetateDrug
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
| Study group | Role | What they receive |
|---|---|---|
| ganirelix | Experimental | multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met Receives: Drug: Ganirelix Acetate |
| cetrorelix | Experimental | multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met Receives: Drug: Cetrorelix Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion,an average of 9 months
Secondary outcomes (17)
number of follicles ≥ 14mm on the day of hCG administration
number of follicles ≥ 14mm
Measured: through study completion,an average of 9 months
FSH serum levels on the day of hCG administration
mUI/ml
Measured: through study completion,an average of 9 months
FSH on the day of antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
FSH serum level on the day after the antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
LH serum level on the day of antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
LH serum level on the day after the antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
E2 serum level on the day of antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
E2 serum level on the day after the antagonist administration
mUI/ml
Measured: through study completion,an average of 9 months
number of oocyte retrieved
how many oocyte were retrieved on transvaginal oocyte retrieval
Measured: 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
Measured: through study completion,an average of 9 months
embryos obtained for patients
how many embryos were obtained for patient for each arm
Measured: 72 hours after transvaginal oocyte retrieval
grade A embryos transferred
number of grade A embryo were transferred for patient
Measured: 72 hours after transvaginal oocyte retrieval
total dose of gonadotropins administered
number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
Measured: through study completion,an average of 9 months
duration of gonadotropin treatment
how many days were necessary to complete the Controlled Ovarian Hyperstimulation
Measured: through study completion,an average of 9 months
percentage of patients developing OHSS
how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
Measured: 15 days after the transvaginal oocyte retrieval
implantation rate
The number of gestational sacs observed divided by the number of embryos transferred.
Measured: 30 days after the embyo transfer
pregnancy rate
The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred
Measured: 14 days after the transvaginal oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start15 Nov 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility/SterilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Iacovelli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Investigators
- Gian Mario Tiboni, professor, Study director, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477929
- Sponsor's protocol ID
- Cetrorelix-Ganirelix
- Acronym
- IVF
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03477929
- Acronym / sponsor ID
- IVF / Cetrorelix-Ganirelix
- Conditions
- Infertility/Sterility
- Keywords
- In vitro fertilization, gnrh antagonist, pituitary suppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ganirelix | Experimental | Drug: Ganirelix Acetatemultiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
| cetrorelix | Experimental | Drug: Cetrorelix Acetatemultiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganirelix Acetatemultiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met | Drug | ganirelix |
| Cetrorelix Acetatemultiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met | Drug | cetrorelix |
Primary outcome
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.
17 secondary outcomes
number of follicles ≥ 14mm on the day of hCG administration
Time frame: 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
FSH on the day of antagonist administration
Time frame: 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
LH serum level on the day of antagonist administration
Time frame: 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
E2 serum level on the day of antagonist administration
Time frame: 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
number of oocyte retrieved
Time frame: through study completion,an average of 9 months
number of metaphase II oocyte retrieved
Time frame: through study completion,an average of 9 months
embryos obtained for patients
Time frame: 72 hours after transvaginal oocyte retrieval
grade A embryos transferred
Time frame: 72 hours after transvaginal oocyte retrieval
total dose of gonadotropins administered
Time frame: through study completion,an average of 9 months
duration of gonadotropin treatment
Time frame: through study completion,an average of 9 months
percentage of patients developing OHSS
Time frame: 15 days after the transvaginal oocyte retrieval
implantation rate
Time frame: 30 days after the embyo transfer
pregnancy rate
Time frame: 14 days after the transvaginal oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Mario Tiboni, professor study director
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganirelix Acetate and Cetrorelix Acetate in people with Infertility/Sterility, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gian Mario Tiboni, professor (347 8787545, tiboni@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum LH levels (time frame: through study completion,an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.