Low-dose GH Supplementation Increases Clinical Pregnancy Rate

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359695
• Other study ID #: CIRH-BROHC-2013
• Secondary ID: 2013-003123-11
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2015
• Last updated: May 9, 2017
• Start date: October 2013
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Centro de Infertilidad y Reproducción Humana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Spain	Centro de Infertilidad y Reproducción Humana (CIRH)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Infertilidad y Reproducción Humana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound	7 weeks of gestation
Secondary	Retrieved oocytes	Total number of retrieved oocytes	On egg retrieval day
Secondary	Number of obtained embryos	Total number of obtained embryos	3 days after egg retrieval
Secondary	Embryo quality	Total number of top quality embryos per cycle	3 days after embryo transfer
Secondary	Proportion of cycles with embryo transfer	Proportion of cycles reaching embryo transfer per initiated cycle	3 days after egg retrieval