The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

What Was Tested

The trial (phase 4) is built around HMG (Human Menopausal Gonadotropin).

To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

The registry classes the interventions as drug.

Who Took Part

150 planned participants were the target.

It was open to women only aged from 18 years up to 38 years.

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

Examples of who could join: Females between the ages of 18- 38 years (both included) at the time of randomisation. Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre. Infertility for at least 1 year before randomisation (except for tubal infertility). A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy. 25- 34 days of menstruation cycle.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study; undiagnosed vaginal bleeding; tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus.

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 HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2006-04.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Circulatory levels of Estradiol on the day of hCG.

It also tracked 14 secondary outcomes, for example E2 per follicle >14 mm, Total number of oocytes retrieved, fertilization rate, implantation rate, transferable embryos and Clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 150 people.

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.