Hormone Evaluation in Artificial Reproductive Technology

What Was Tested

The trial (not phased) is built around HMG (Human Menopausal Gonadotropin).

The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation.

Outcome will be measured as pregnancy success, live born babies and unwanted side effects.

It had two arms (groups): Follitropin alpha (active comparator) and Menotropin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The hypothesis is that genetic variants in the gonadotropin receptors (LH and FSH receptors), are influencing the outcome.

This finding was not stressed in the manuscript as it could have been due to chance because of the small number of women treated with menotropin.

In total 890 women, 445 in Poznan, Poland and 445 in Malmö, Sweden, with unexplained infertility or a male or tubal factor indication for treatment will be invited to participate in the study.

At first appointment, information is provided and informed consent retrieved.

Who Took Part

810 actual participants took part.

It was open to women only aged from 25 years up to 40 years.

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

Examples of who could join: Normal ovulatory cycles 26-32 days. First and second IVF treatment. Indication for IVF is male factor, tubal factor or unexplained infertility. Medical indication for IVF; \>12 months unprotected intercourse.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: polycystic ovarian syndrome; pre ovarian failure; male age more than 56.

How the Study Was Run

The set-up was non-randomized, parallel-group and double-blind.

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

Neither the participants nor the staff measuring them knew who was on HMG (Human Menopausal Gonadotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2016-09 with completion listed for 2021-12-31.

It ran at 2 sites in Poland (1) and Sweden (1).

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Pregnancy (time frame: up to 12 months after treatment).

It also tracked 2 secondary outcomes, for example Number of oocytes and live birth.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of HMG (Human Menopausal Gonadotropin) in 810 people.

With 810 participants it is a large trial for this field.

The trial is marked completed; 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.