Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Short name IVF

NCTNCT03477929Other idCetrorelix-Ganirelix

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 100 participants (estimated)
Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Italy
Start: 15 Nov 2017
Primary completion: 15 Dec 2018 (estimated)
Completion: 15 Jan 2019 (estimated)
First posted: 27 Mar 2018
Last update posted: 27 Mar 2018
Conditions: Infertility/Sterility

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020

Ph 4
IVF
NCT03477929
15 Nov 2017 to est. 15 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Ganirelix AcetateDrug
Cetrorelix AcetateDrug

Arms2

Experimental
ganirelix
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

Primary outcomes1

Outcomes the sponsor listed as primary.

serum LH levels
Time frame · through study completion,an average of 9 months
Registry description
percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.

Secondary outcomes(17)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 39 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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