Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation

What Was Tested

This registered phase 2 trial tested hCG (human chorionic gonadotropin).

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who 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: No more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory; severe ohss in a previous controlled ovarian stimulation cycle.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2022-10-04 with completion listed for 2024-03-25.

It ran at 3 sites in Spain (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of metaphase II (MII) oocytes (time frame: On the day of oocyte retrieval (2 days after triggering)).

It also tracked 22 secondary outcomes, for example Number of oocytes retrieved, Number of fertilised (2 pronuclei) oocytes, Number and quality of embryos on day 3 after oocyte retrieval, Number and quality of blastocysts on day 5 after oocyte retrieval, Serum hormone concentrations of progesterone and Serum hormone concentrations of 17-OH-progesterone.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.