The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin.

It had two arms (groups): early follicular phase down-regulation (experimental) and luteal phase down-regulation (active comparator).

The registry classes the interventions as drug.

More on the Plan

According to the 2015 national data published by Human Fertility and Embryology Authority (HFEA, 48,147 women received 61,726 IVF/ICSI cycles and gave birth to 17,041 newborns.

In the United States, 169,602 IVF/ICSI cycles were performed in 2014 and 68,791 tubal babies were born.

The IVF/ICSI success rate in 2014 in the US is similar.

Who Took Part

1892 planned participants were the target.

It was open to women only aged from 20 years up to 35 years.

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

Examples of who could join: Women with a normal ovarian reserve according to: ①basal steroid hormone on day 2-4 of menstrual cycle: basal FSH≤10mIU/ml, estradiol (E2) \<50pg/ml;②1.5\<anti-Müllerian hormone (AMH)\<4.0；③8≤antral follicle count (AFC) ≤15;. BMI≥18 and ≤25kg/m2;.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: women with a negative reproductive history, including a history of:; women with a history of one side adnexectomy;; women with a poor ovarian response or diminished ovarian reserve (based on bologna' criteria);.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Triptorelin 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.

In this single-blind Triptorelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-02-01 with completion listed for 2020-09-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: live birth rate per transferred cycle (time frame: 28 weeks of gestation).

It also tracked 8 secondary outcomes, for example live birth rate per stimulated cycle, biochemical pregnancy rate per stimulated cycle, clinical pregnancy rate per stimulated cycle, ongoing pregnancy rate per stimulated cycle, biochemical pregnancy rate per transferred cycle and clinical pregnancy rate per transferred cycle.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 1892 people.

With 1892 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 Triptorelin compound page, all human trials.