Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders

What Was Tested

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

It had two arms (groups): Corifollitropin alfa and menotropin (active comparator) and Follitropin alfa and lutropin alfa (active comparator).

The registry classes the interventions as drug.

More on the Plan

Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to morula or blastocyst stage followed by ultrasound guided single or double embryo transfer (ET day, performed 4-5 days after OPU).

Who Took Part

The registry lists 32 actual participants took part.

It was open to women only aged from 35 years up to 41 years.

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

Examples of who could join: Female age between 35-41 years;. BMI 17,5-30 kg/m2;. Presence of viable spermatozoa in partner's sperm;. Signed informed consent.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: abnormal ivf screening tests: papanicolaou test, syphilis, hiv 1\&2, hepatitis b, hepatitis c, chlamydia, and gonorrhea;; presence of uterine pathology: asherman's syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids ≥3 mm in diameter;; visualization of ovarian cysts ≥25 mm, endometriomas or hydrosalpinx;.

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2017-09-04 with completion listed for 2018-11-02.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of cumulus-oocyte complexes (COCs) (time frame: 3-4 weeks after ET).

It also tracked 9 secondary outcomes, for example Duration of stimulation, Number of follicles at the end of stimulation, Number of participants with optimal or suboptimal response to COS, Number of mature (MII) oocytes, Cycle cancellation rate and Frequency of side reactions.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 32 people.

Its size is small, so on its own it can only give an early look.

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.