Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) and Cetrorelix for female fertility.

It had two arms (groups): Menotrophin (experimental) and Follitrophin Alpha (active comparator).

The registry classes the interventions as drug.

Who Took Part

124 actual participants took part.

It was open to women only aged from 34 years up to 42 years.

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

Examples of who could join: Signed informed consent. Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment. Aged ≥34 and ≤42 years. Body mass index of \>18 and \<28 kg/m\^2. Normal pelvic ultrasound at Screening.

The full record lists 12 inclusion and 7 exclusion criteria; among the exclusions: presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus); A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia; A history of coagulation disorders.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2010-10 with completion listed for 2013-01.

It ran at 8 sites in Germany (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration (time frame: approximately day 10).

It also tracked 17 secondary outcomes, for example Percentage of Participants With Ongoing Pregnancy, Number of Follicles at hCG Administration, Average Follicle Diameter at hCG Administration, Number of Cumulus-oocyte Complexes Retrieved, Number of Pronuclear Oocytes and Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) and Cetrorelix in 124 people with female fertility.

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

More context: the hCG (human chorionic gonadotropin) compound page and the Cetrorelix compound page, Female fertility research.