The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

What Was Tested

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

It had two arms (groups): Human menopausal gonadotropin (HMG) (experimental) and Routine care (no intervention).

This group will receive the routine care for luteal phase support.

The registry classes the interventions as drug.

More on the Plan

Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups.

Long agonist protocol will be used.

Allocation to either one of 2 groups will be done on the day of oocytes retrieval.

The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks.

Who Took Part

The registry lists 600 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles. Age between 20 and 40 years.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: females who have high response (estradiol at time of ovulation trigger is \> 5000 pg/ml or more than 15 oocytes are retrieved).

How the Study Was Run

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

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.

Everyone knew when HMG (Human Menopausal Gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-07-06 with completion listed for 2024-07-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Live birth rate (time frame: This outcome will be calculated 2 years after enrollment of the first patient in the study).

It also tracked 3 secondary outcomes, for example Clinical pregnancy rate, Implantation rate and Miscarriage rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 600 people.

With 600 participants it is a large trial for this field.

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.