Cetrorelix and Ganirelix Flexible Protocol for (IVF)

What Was Tested

This registered phase 4 trial tested Cetrorelix.

Recombinant gonadotropins are currently used for ovarian stimulation in women undergoing to IVF for infertility.

It had two arms (groups): ganirelix (experimental) and cetrorelix (experimental).

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

It was open to women only aged from 18 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cetrorelix study: the participants and staff both knew the treatment.

It started in 2017-11-15 with completion listed for 2018-12-15.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: serum LH levels (time frame: through study completion,an average of 9 months).

It also tracked 17 secondary outcomes, for example number of follicles ≥ 14mm on the day of hCG administration, FSH serum levels on the day of hCG administration, FSH on the day of antagonist administration, FSH serum level on the day after the antagonist administration, LH serum level on the day of antagonist administration and LH serum level on the day after the antagonist administration.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cetrorelix in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.