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Completed

NCT Number: NCT02359695

Low-dose GH Supplementation Increases Clinical Pregnancy Rate

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Centro de Infertilidad y Reproducción Humana (CIRH)

Barcelona, 08017, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centro de Infertilidad y Reproducción Humana

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 10, 2015
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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