The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment

What Was Tested

The trial (phase 2) is built around Kisspeptin-10 and Kisspeptin-54.

The researchers want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during IVF therapy for infertility.

It had ten arms (groups): Kisspeptin-54, 1.6 single (experimental), Kisspeptin-54, 3.2 single (experimental), Kisspeptin-54, 6.4 single (experimental), Kisspeptin-54, 12.8 single (experimental) and Kisspeptin-54 OHSS, 3.2 single (experimental).

The registry classes the interventions as drug.

More on the Plan

Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.

The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured.

Who Took Part

175 actual participants took part.

It was open to women only aged from 18 years up to 34 years.

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

Examples of who could join: Aged 18 - 34 years. Body mass index between 18 and 29 kg/m2. Stable body weight for at least 3 months. Normal early menstrual cycle follicular phase serum FSH concentration. No more than one previous IVF treatment cycle.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study; treatment with an investigational drug within the preceding 2 months; donated blood during the preceding 3 months or intention to do so before the end of the study.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Kisspeptin-10 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.

Neither the participants nor the staff measuring them knew who was on Kisspeptin-10, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2012-06-01 with completion listed for 2016-10-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Oocyte Maturation (time frame: 36 hours post Kisspeptin-54 trigger injection).

It also tracked 5 secondary outcomes, for example Biochemical Pregnancy, Occurrence of OHSS, Fertilization Rate, Embryo Formation and Number of Participants With Clinical Pregnancy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Kisspeptin-10 and Kisspeptin-54 in 175 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Kisspeptin-10 compound page and the Kisspeptin-54 compound page, all human trials.