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Low-dose GH Supplementation Increases Clinical Pregnancy Rate

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ClinicalTrials.gov Identifier: NCT02359695
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Centro de Infertilidad y Reproducción Humana

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Growth Hormone Phase 1

Detailed Description:

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: GH cycle
Subsequent IVF cycle, supplemented with a low dose of growth hormone.
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 Name: Somatotropin




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 7 weeks of gestation ]
    Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound


Secondary Outcome Measures :
  1. Retrieved oocytes [ Time Frame: On egg retrieval day ]
    Total number of retrieved oocytes

  2. Number of obtained embryos [ Time Frame: 3 days after egg retrieval ]
    Total number of obtained embryos

  3. Embryo quality [ Time Frame: 3 days after embryo transfer ]
    Total number of top quality embryos per cycle

  4. Proportion of cycles with embryo transfer [ Time Frame: 3 days after egg retrieval ]
    Proportion of cycles reaching embryo transfer per initiated cycle



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359695


Locations
Spain
Centro de Infertilidad y Reproducción Humana (CIRH)
Barcelona, Spain, 08017
Sponsors and Collaborators
Centro de Infertilidad y Reproducción Humana
Investigators
Study Director: Mario Brassesco, MD Centro de Infertilidad y Reproducción Humana

Responsible Party: Centro de Infertilidad y Reproducción Humana
ClinicalTrials.gov Identifier: NCT02359695     History of Changes
Other Study ID Numbers: CIRH-BROHC-2013
2013-003123-11 ( EudraCT Number )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Centro de Infertilidad y Reproducción Humana:
Poor ovarian response
IVF
Growth hormone

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs