InfertilityPhase 1NCT02359695
Low-dose GH Supplementation Increases Clinical Pregnancy Rate
A Phase 1 study testing Growth Hormone in people with Infertility, run by Centro de Infertilidad y Reproducción Humana at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Growth Hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a history of POR, defined according to the Bologna criteria
- Absence of pregnancy in at least two previous IVF cycles
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Infertilidad y Reproducción Humana (CIRH)
Barcelona, 08017
About this study
Official title: Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
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.
Read the 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
- Being tested
- Growth Hormone
- Keywords
- Poor ovarian response, IVF, Growth hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Also called Somatotropin
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
| Study group | Role | What they receive |
|---|---|---|
| GH cycle | Experimental | Subsequent IVF cycle, supplemented with a low dose of growth hormone. Receives: Drug: Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
Measured: 7 weeks of gestation
Secondary outcomes (4)
Retrieved oocytes
Total number of retrieved oocytes
Measured: On egg retrieval day
Number of obtained embryos
Total number of obtained embryos
Measured: 3 days after egg retrieval
Embryo quality
Total number of top quality embryos per cycle
Measured: 3 days after embryo transfer
Proportion of cycles with embryo transfer
Proportion of cycles reaching embryo transfer per initiated cycle
Measured: 3 days after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Infertilidad y Reproducción Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Brassesco, MD, Study director, Centro de Infertilidad y Reproducción Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359695
- Sponsor's protocol ID
- CIRH-BROHC-2013
- Other IDs
- 2013-003123-11
- Status last verified
- May 2017
- First submitted
- 5 Feb 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.
- ClinicalTrials.gov ID
- NCT02359695
- Acronym / sponsor ID
- CIRH-BROHC-2013
- Conditions
- Infertility
- Keywords
- Poor ovarian response, IVF, Growth hormone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centro de Infertilidad y Reproducción HumanaUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH cycle | Experimental | Drug: Growth HormoneSubsequent IVF cycle, supplemented with a low dose of growth hormone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with a history of POR, defined according to the Bologna criteria
- Absence of pregnancy in at least two previous IVF cycles
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth HormoneAlso: SomatotropinA 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 | Drug | GH cycle |
Primary outcome
Clinical pregnancy rate
Time frame: 7 weeks of gestation
Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound
4 secondary outcomes
Retrieved oocytes
Time frame: On egg retrieval day
Number of obtained embryos
Time frame: 3 days after egg retrieval
Embryo quality
Time frame: 3 days after embryo transfer
Proportion of cycles with embryo transfer
Time frame: 3 days after egg retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Brassesco, MD study director
Centro de Infertilidad y Reproducción Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Growth Hormone in people with Infertility, run by Centro de Infertilidad y Reproducción Humana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 7 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.