title: 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.
  
  
  METHODS
  Parallel randomized, controlled, open-label trial.
  
  
  METHODS
  University hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  Patients received the antagonist protocol with or without GH supplementation.
  
  
  METHODS
  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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02195947.
authors.affiliation: Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt. Electronic address: yasminbassiouny@gmail.com.
authors.forename: Yasmin Ahmed
authors.initials: YA
authors.lastname: Bassiouny
authors.affiliation: Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.
authors.forename: Dina Mohamed Refaat
authors.initials: DMR
authors.lastname: Dakhly
authors.affiliation: Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.
authors.forename: Yomna Ali
authors.initials: YA
authors.lastname: Bayoumi
authors.affiliation: Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.
authors.forename: Nawara Mohamed
authors.initials: NM
authors.lastname: Hashish
mesh_terms: D000022:Abortion, Spontaneous / Q000209:etiology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004534:Egypt; D010064:Embryo Implantation; D004624:Embryo Transfer; D005260:Female; D005298:Fertility / Q000187:drug effects*; D005300:Fertility Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D005307:Fertilization in Vitro / Q000009:adverse effects; D006785:Hospitals, University; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007246:Infertility / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D050498:Live Birth; D054315:Oocyte Retrieval; D011247:Pregnancy; D018873:Pregnancy Rate; D020554:Sperm Injections, Intracytoplasmic / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005300:Fertility Agents, Female; D019382:Human Growth Hormone
keywords: Antagonist protocol; IVF/ICSI; poor ovarian response; poor responders