DuoStim in Cases of PGT: Comparison of Embryo Quantity and Embryonic Quality Using MitoScore

What Was Tested

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

Since preimplantation genetic testing (PGT) is being more frequently requested from patients as women pursue infertility treatments at an advanced age with a poorer prognosis, sometimes physicians are compelled to perform several stimulation cycles to obtain more eggs and, consequently, a greater number of biopsied embryos.

Hence, the idea of carrying out this study arises as an attempt to optimize each menstrual cycle to the maximum.

It had two arms (groups): DuoStim (experimental) and Conventional Stimulation (active comparator).

The registry classes the interventions as diagnostic test, drug and procedure.

More on the Plan

Classically, the follicular development was thought to occur only during the follicular phase of the menstrual cycle.

Some authors insist that follicles formed during the luteal phase may have a similar ovulation potential of those formed in the follicular phase, thus offering new possibilities for ovarian stimulation.

Because of the accumulated experience with these new approaches, some investigators have recently proposed a double stimulation (DuoStim) protocol.

Evidence of the competence of oocytes obtained from the luteal phase have been recently defined and published.

Who Took Part

136 actual participants took part.

It was open to women only aged from 35 years up to 42 years.

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

Examples of who could join: Signed informed consent;. 35-42 years of age;. BMI 18-30 kg/m2;. Suspicion of suboptimal or poor response:.

The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: simultaneous participation in another clinical trial or in any other study that could result in a confounding factor.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

It started in 2017-12-01 with completion listed for 2019-12-01.

It ran at 1 site in Spain.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Rate of euploid embryos per cycle (time frame: up to 9 months).

It also tracked 8 secondary outcomes, for example Number of oocytes obtained, Number of fertilized oocytes, Number of biopsied blastocysts, MitoScore index of the euploid embryos, Implantation rate and Pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 136 people.

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.