Clinical trial NCT02359695: Low-dose GH Supplementation Increases Clinical Pregnancy Rate
Official title: Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Keywords: Poor ovarian response
IVF
Growth hormone
Lead sponsor: Centro de Infertilidad y Reproducción Humana
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks of gestation
Secondary outcomes:
measure: Retrieved oocytes
timeFrame: On egg retrieval day
measure: Number of obtained embryos
timeFrame: 3 days after egg retrieval
measure: Embryo quality
timeFrame: 3 days after embryo transfer
measure: Proportion of cycles with embryo transfer
timeFrame: 3 days after egg retrieval
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro de Infertilidad y Reproducción Humana (CIRH)
Study officials:
affiliation: Centro de Infertilidad y Reproducción Humana
name: Mario Brassesco, MD
role: STUDY_DIRECTOR
References: