Low-dose GH Supplementation Increases Clinical Pregnancy Rate

NCT ID: NCT02359695

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-05-31

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.

Conditions

Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GH cycle

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

Group Type: EXPERIMENTAL

Growth Hormone

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Somatotropin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro de Infertilidad y Reproducción Humana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Brassesco, MD

Role: STUDY_DIRECTOR

Centro de Infertilidad y Reproducción Humana

Locations

Centro de Infertilidad y Reproducción Humana (CIRH)

Barcelona, , Spain

Countries

Spain

Other Identifiers

2013-003123-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIRH-BROHC-2013

Identifier Type: -

Identifier Source: org_study_id