Low-dose GH Supplementation Increases Clinical Pregnancy Rate

Phase 1

Completed

• Conditions: Infertility
• Interventions: Drug: Growth Hormone

• Registration Number: NCT02359695
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-10
• Primary Completion: 2016-12
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GH cycle	Growth Hormone	Subsequent IVF cycle, supplemented with a low dose of growth hormone.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	7 weeks of gestation	Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound

Secondary Outcome Measures

Name	Time	Method
Retrieved oocytes	On egg retrieval day	Total number of retrieved oocytes
Number of obtained embryos	3 days after egg retrieval	Total number of obtained embryos
Embryo quality	3 days after embryo transfer	Total number of top quality embryos per cycle
Proportion of cycles with embryo transfer	3 days after egg retrieval	Proportion of cycles reaching embryo transfer per initiated cycle

Trial Locations

Locations (1)

Centro de Infertilidad y Reproducción Humana (CIRH); 🇪🇸 Barcelona, Spain