Synchronization of Ovarian Stimulation for in Vitro Fertilization With Follicular Wave Emergence

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin).

Ovarian stimulation is an important phase of in vitro fertilization (IVF) treatments.

The harvest of a larger number of viable eggs per cycle compensate eventual laboratory difficulties and allow for the selection of embryos with higher implantation potential.

In the current protocols, based on the most prevailing theory of ovarian follicular development, stimulation drugs are usually started on the second or third day after the beginning of menses.

It had three arms (groups): Control (active comparator), Ovulation induction (experimental) and Dominant follicle aspiration (experimental).

The registry classes the interventions as drug, other and procedure.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Age \< 35 years old. Body mass index: 19-30 kg/m2. Tubal or male factor infertility with indication of in vitro fertilization. Antral follicle count: 10-20. Normal uterus in transvaginal ultrasound scan.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: ovarian factor infertility; non identification of one or both ovaries in the transvaginal ultrasound scan; non treated endocrine disorders.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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

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

It started in 2012-01 with completion listed for 2014-12.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Emergence of an ovarian follicular wave after dominant follicle aspiration or hCG administration (time frame: One year). Follicular growth pattern on ultrasound scan (time frame: One year).

It also tracked 5 secondary outcomes, for example Estradiol and progesterone levels during ovarian stimulation, Number of mature oocytes retrieved, Fertilization rate and Pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; 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.