Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval

What Was Tested

This registered phase 2 trial tested Triptorelin.

The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles.

It had four arms (groups): DECAPEPTYL® diario (experimental), Decapeptyl® diaro (experimental), Decapeptyl® diario. (experimental) and Decapeptyl® daily (active comparator).

Group 1: DECAPEPTYL® diario,OPU 24 hours after GnRHa administration.

Group 2:Decapeptyl® diario OPU 30 hours after GnRHa administration.

Group 3: Decapeptyl® diario, OPU 40 hours after GnRHa administration.

The registry classes the interventions as drug.

More on the Plan

Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades.

When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG.

The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.

From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h).

Who Took Part

The registry lists 130 actual participants took part.

It was open to women only aged from 18 years up to 37 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women between 18 and 37 years of age at the time of randomization (both ages included). Antral follicle count \> 6 and \< 24. Number of follicles ≥ 16 mm \> 5 on the ovulation induction day.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: presence of severe endometriosis (grade iii-iv); absence of one ovary due to previous surgery; diagnosis of polycystic ovary syndrome (defined according to the rotterdam criteria).

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Triptorelin was given.

Those kept unaware of assignments: investigator.

It started in 2014-09 with completion listed for 2018-02-01.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of mature oocytes 24 hours post Decapeptyl administration (time frame: 24 hours post Decapeptyl administration). Number of mature oocytes 30 hours post Decapeptyl administration (time frame: 30 hours post Decapeptyl administration). Number of mature oocytes 36 hours post Decapeptyl administration (time frame: 36 hours post Decapeptyl administration).

It also tracked 4 secondary outcomes, for example Total number of follicles > 16 mm punctured, Total number of oocytes retrieved, Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin and Serum and follicular fluid hormonal levels (estradiol , LH and progesterone).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 130 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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