Trial | NCT02359695  Report issue

Title

Low-dose GH Supplementation Increases Clinical Pregnancy Rate
Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin ...

  • Study Participants

    64
The objective of this study is to assess whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.
The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer.

Controlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation.

After confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached > 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.
Study Started
Oct 31
2013
Primary Completion
Dec 31
2016
Study Completion
May 31
2017
Last Update
May 10
2017

Drug Growth Hormone

A dose of 0.5 IU of growth hormone will be administered daily from the first day of the agonist until the day of hCG administration

  • Other names: Somatotropin

GH cycle Experimental

Subsequent IVF cycle, supplemented with a low dose of growth hormone.

Criteria 

Inclusion Criteria:

Women with a history of POR, defined according to the Bologna criteria
Absence of pregnancy in at least two previous IVF cycles

Exclusion Criteria:

Body mass index ≥ 30 kg/m2
Presence of endocrinopathies
Altered karyotype in one or both partners
History of invasive ovarian surgery
History of chronic, autoimmune or metabolic diseases
Altered meiosis in testicular biopsy or altered sperm-FISH
Drug therapy in the male partner
Participation, within the previous 6 months, in another clinical trial with medication
No Results Posted