Efficacy and Safety of Medication Used to Stimulate Ovulation

What Was Tested

The trial (phase 4) is built around Leuprolide.

Ovarian follicular responsiveness to COH with gonadotropins is extremely variable between patients and even from cycle to cycle for the same patient.

Achieving an ideal follicular response is critical to the success of assisted reproduction treatment (ART).

It had six arms (groups): Study group: High Responders (experimental), Control group: High Responders (no intervention), Study group: Normal Responders (experimental), Control group: Normal Responders (no intervention) and Study group: Low Responders (experimental).

The registry classes the interventions as drug.

More on the Plan

Ovarian follicular responsiveness to controlled ovarian hyperstimulation (COH) with gonadotropins is extremely variable between patients and even from cycle to cycle for the same patient.

Since the early years of ART, patients have been classified as 'poor', 'normal' or 'high' responders.

Although these terms are widely used in research and in daily clinical practice, their precise definitions are not fully agreed upon.

Distinguishing them has been based on various measures of ovarian reserve.

Who Took Part

666 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: AFC \> 16. Previous cycle cancellation due to OHSS risk. Informed consent obtained. Must be 18 years or older. Ability to speak and read English, or understand French, Mandarin, Cantonese, Arabic, or Filipino.

The full record lists 10 inclusion and 26 exclusion criteria; among the exclusions: chronic disease; hypogonadotrophic hypogonadism; untreated uterine abnormalities.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The Leuprolide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-10 with completion listed for 2020-09.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Implantation rate (time frame: 14 days post IVF procedure). Human Chorionic Gonadotropin serum levels (time frame: 2-4 weeks post IVF procedure). Ongoing pregnancy rate (time frame: 9 months post IVF procedure).

It also tracked 5 secondary outcomes, for example Number of retrieved oocytes, Number of retrieved Meiosis II oocytes, Fertilization rate, Number of Day 3 embryos/eggs retrieved and Number of blastocysts/eggs retrieved.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 666 people.

With 666 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.