Current partner codePEPTIDESDE
NCT03477929·Phase 4·INTERVENTIONAL

Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Status

Unknown

Phase

Phase 4

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Ganirelix Acetate

multiple dose of Ganirelix 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

Timeline

From registration to results.

  1. First posted

    Mar 27, 2018

  2. Study start

    Nov 15, 2017

  3. Primary completion

    Dec 15, 2018

  4. Study completion

    Jan 15, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Mar 27, 2018

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

number of follicles ≥ 14mm on the day of hCG administration

Time frame · through study completion,an average of 9 months

number of follicles ≥ 14mm

FSH serum levels on the day of hCG administration

Time frame · through study completion,an average of 9 months

mUI/ml

FSH on the day of antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

FSH serum level on the day after the antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

LH serum level on the day of antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

LH serum level on the day after the antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

E2 serum level on the day of antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

E2 serum level on the day after the antagonist administration

Time frame · through study completion,an average of 9 months

mUI/ml

number of oocyte retrieved

Time frame · through study completion,an average of 9 months

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

how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

Ospedale Bernabeo

Ortona, Chieti, Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

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