Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): a study protocol for a randomised controlled trial

What Was Tested

This randomized controlled trial looks at hCG (human chorionic gonadotropin).

Thus, there is a need to test the concept against standard care in a randomised controlled design.

This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial.

The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer.

Why It Was Studied

The study will be performed in accordance with the ethical principles in the Helsinki Declaration.

The study is approved by the Scientific Ethical Committees in Denmark and Sweden.

Who Took Part

The age groups tagged for this paper are young adults and adults, women only.

Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden.

Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle.

How the Study Was Run

The design is described as randomized, double-blind and multicenter.

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

Blinding on both sides kept the participants and researchers unaware of who received hCG (human chorionic gonadotropin).

More than one site took part, so the participants came from several places.

What Was Measured

Topics PubMed links to this paper include Chorionic Gonadotropin, Cryopreservation, Denmark, Embryo Transfer, Gonadotropin-Releasing Hormone, Ovulation Induction and Pregnancy Rate.

The authors tagged it with the keywords ART, FET, Freeze-all, Ongoing pregnancy rate and RCT.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of hCG (human chorionic gonadotropin).

The publication is from 2017 (BMJ open), a journal based in England.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.