Low-dose GH Supplementation Increases Clinical Pregnancy Rate
Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
2 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 10, 2017
May 1, 2017
3.2 years
February 5, 2015
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
7 weeks of gestation
Secondary Outcomes (4)
Retrieved oocytes
On egg retrieval day
Number of obtained embryos
3 days after egg retrieval
Embryo quality
3 days after embryo transfer
Proportion of cycles with embryo transfer
3 days after egg retrieval
Study Arms (1)
GH cycle
EXPERIMENTALSubsequent IVF cycle, supplemented with a low dose of growth hormone.
Interventions
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
Eligibility Criteria
You may qualify if:
- Women with a history of POR, defined according to the Bologna criteria
- Absence of pregnancy in at least two previous IVF cycles
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Infertilidad y Reproducción Humana (CIRH)
Barcelona, 08017, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mario Brassesco, MD
Centro de Infertilidad y Reproducción Humana
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2015
First Posted
February 10, 2015
Study Start
October 1, 2013
Primary Completion
December 1, 2016
Study Completion
May 1, 2017
Last Updated
May 10, 2017
Record last verified: 2017-05