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GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response

Plain-language guide to NCT02144818: not phased randomized trial of Triptorelin, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02144818
Phase
not phased
Status
status unknown
Start
2014-01
Completion (planned or actual)
2015-07
Participants
60 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Women With Poor Ovarian Response
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Triptorelin.

During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo.

However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.

Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG.

It had three arms (groups): GnRH agonist (active comparator), hCG (active comparator) and dual triggering: GnRH agonist and hCG (active comparator).

The registry classes the interventions as drug.

More on the Plan

Inclusion criteria: * Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

Exclusion criteria: * Women with good ovarian response. * Women with low ovarian response who are carriers of fragile X.

Who Took Part

60 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: women with good ovarian response; women with low ovarian response who are carriers of fragile x.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

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

Being open-label, the Triptorelin study did not mask who received what.

It started in 2014-01 with completion listed for 2015-07.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The main outcome is the number of mature oocytes (time frame: up to 12 months). number of embryos appropriate for transfer (time frame: up to 12 month).

It also tracked 1 secondary outcome, for example pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 60 people.

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

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

Our Notes on the Compound

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.