Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial

Abstract

Objective: To evaluate the effectiveness of the addition of growth hormone (GH) to the antagonist protocol in IVF/intracytoplasmic sperm injection cycles in poor responders.

Design: Parallel randomized, controlled, open-label trial.

Setting: University hospital.

Patient(s): A total of 141 patients (GH, n = 68; gonadotropins only, n = 73) were enrolled. Twenty-five patients had their cycles cancelled. Analysis was performed per cycle start as well as per ET.

Intervention(s): Patients received the antagonist protocol with or without GH supplementation.

Main outcome measure(s): Mean number of cumulus complexes, metaphase II oocytes retrieved and fertilized, chemical and clinical pregnancy rates, early miscarriage rate, ongoing pregnancy and live birth rates.

Result(s): The addition of GH significantly lowered duration of hMG treatment, duration of GnRH antagonist treatment, and dose of gonadotropin. It significantly increased mean E2 levels on the day of hCG administration, number of collected oocytes (7.58 ± 1.40 vs. 4.90 ± 1.78 [mean ± SD]), number of metaphase II oocytes (4.53 ± 1.29 vs. 2.53 ± 1.18), number of fertilized oocytes (4.04 ± 0.96 vs. 2.42 ± 1.03), and number of transferred embryos (2.89 ± 0.45 vs. 2.03 ± 0.81). There was no significant difference in the clinical pregnancy rate per cycle (22.1% vs. 15.1%) or live birth rate per cycle (14.7% vs. 10.9%).

Conclusion(s): Growth hormone as an adjuvant treatment in IVF/intracytoplasmic sperm injection cycles for poor responders should be cautiously used with the antagonist protocol, because there is still no identified impact on pregnancy outcomes. However, evaluation of the clinical pregnancy and live birth rates in our data was limited by low statistical power.

Clinical trial registration number: ClinicalTrials.gov Identifier: NCT02195947.

Keywords: Antagonist protocol; IVF/ICSI; poor ovarian response; poor responders.

Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.