Luteal Phase Support in Insemination Cycles

What Was Tested

This registered phase 4 trial tested Triptorelin.

This study is a prospective randomized trial with 242 IUI cycles.

Patients are randomized in two groups including 121 cycles in each group.

A total of 255 cycles in 167 patients are finally recruited.

It had two arms (groups): Gonapeptyl (experimental) and Control group (no intervention).

In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle.

In the control group, there are no luteal phase medications in the insemination cycle.

The registry classes the interventions as drug.

Who Took Part

167 actual participants took part.

It was open to women only aged from 18 years up to 43 years.

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

Examples of who could join: \- Patients with ovarian stimulation cycles preparing to insemination. Patients with medical ovarian stimulation protocols including GnRH agonist, aromatase inhibitors and different combinations of GnRH agonists and aromatase inhibitors are included. Patient's willingness to participate in the study.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: \- failure in the ovarian stimulation cycle; failures in executing the insemination; failures in giving the sperm sample.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

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

It started in 2017-01 with completion listed for 2019-11.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Live birth rate (time frame: At possible delivery (about 40 weeks)).

It also tracked 2 secondary outcomes, for example Ongoing pregnancy rate and Miscarriage rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 167 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.