Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders

What Was Tested

This registered not phased trial tested HMG (Human Menopausal Gonadotropin).

Controlled ovarian hyperstimulation (COH) is an important step during in vitro fertilization (IVF).

Its aim optimally is to recruit 10-15 oocytes.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Background: IVF is started after proper evaluation based on an appropriate indication for the treatment.

The first phase of the treatment is the stimulation with the aim to recruit sufficient number of oocytes.

In general, 10-15 oocytes are aimed for.

This many oocytes should be sufficient for the embryology laboratory procedures and should allow the provider to choose the embryo or embryos for transfer from a larger cohort.

Who Took Part

190 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Expected poor responder based on:. AMH: 0.3-1.2 ng/ml or AFC \<5,. AMH\>1.2 ng/ml or AFC≥5 but the retrieval of ≤ 4 oocytes during previous IVF treatment. Motile sperm with normal morphology obtained from the ejaculate of testicular biopsy. No more than 3 previous failed IVF cycles (if the patient had 2 or more previous cycles cancelled for poor response she cannot be included).

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: presence of hydrosalpinx; positive hiv, hepatitis b, c screening tests; planned preimplantation genetic testing of the embryos.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this HMG (Human Menopausal Gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.

It started in 2021-12-02 with completion listed for 2023-07-20.

It ran at 1 site in Hungary.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cumulative Clinical Pregnancy Rate (time frame: 18 months).

It also tracked 2 secondary outcomes, for example Live Birth Rate and Cumulative Live Birth Rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 190 people.

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

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