Low-dose GH Supplementation Increases Clinical Pregnancy Rate
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Growth Hormone
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Poor ovarian response, IVF, Growth hormone
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
Sites / Locations
- Centro de Infertilidad y Reproducción Humana (CIRH)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GH cycle
Arm Description
Subsequent IVF cycle, supplemented with a low dose of growth hormone.
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
Secondary Outcome Measures
Retrieved oocytes
Total number of retrieved oocytes
Number of obtained embryos
Total number of obtained embryos
Embryo quality
Total number of top quality embryos per cycle
Proportion of cycles with embryo transfer
Proportion of cycles reaching embryo transfer per initiated cycle
Full Information
NCT ID
NCT02359695
First Posted
February 5, 2015
Last Updated
May 9, 2017
Sponsor
Centro de Infertilidad y Reproducción Humana
1. Study Identification
Unique Protocol Identification Number
NCT02359695
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Infertilidad y Reproducción Humana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Poor ovarian response, IVF, Growth hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GH cycle
Arm Type
Experimental
Arm Description
Subsequent IVF cycle, supplemented with a low dose of growth hormone.
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Somatotropin
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
Time Frame
7 weeks of gestation
Secondary Outcome Measure Information:
Title
Retrieved oocytes
Description
Total number of retrieved oocytes
Time Frame
On egg retrieval day
Title
Number of obtained embryos
Description
Total number of obtained embryos
Time Frame
3 days after egg retrieval
Title
Embryo quality
Description
Total number of top quality embryos per cycle
Time Frame
3 days after embryo transfer
Title
Proportion of cycles with embryo transfer
Description
Proportion of cycles reaching embryo transfer per initiated cycle
Time Frame
3 days after egg retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Brassesco, MD
Organizational Affiliation
Centro de Infertilidad y Reproducción Humana
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Infertilidad y Reproducción Humana (CIRH)
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
12. IPD Sharing Statement
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Low-dose GH Supplementation Increases Clinical Pregnancy Rate
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