InfertilityPhase 4NCT02412904
Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist
A Phase 4 study testing rFSH and HMG in people with Infertility, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- rFSH and HMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 4
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25 to 40 y
- infertile
- submitted to IVF
- no hormonal disease
- normal FSH (< 10)
- anti-mullerian hormone (AMH) > 1 ng and < 10 ng
- both ovaries
- only first or second IVF
Who cannot join
- thyroid-stimulating hormone (TSH), prolactin (PRL) altered
- endometrioma
- ovarian tumor or cysts
- previous Ovarian Hyperstimulation Syndrome (OHSS)
- severe male factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.
The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.
Read the detailed description
To compare embryonic quality and other clinical outcomes when using human menopause gonadotropin (hMG) or recombinant follicle stimulating hormone (rFSH) to the ovarian stimulation in IVF cycles with the GnRH antagonist protocol.
Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.
Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.
Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.
Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.
- Conditions
- Infertility
- Being tested
- rFSH, HMG
- Keywords
- follicular stimulating hormone, human menopausal gonadotrophin, Recombinant follicular stimulating hormone (rFSH), Gonadotrophin releasing hormone (GnRH) antagonists, GnRH agonist, in vitro fertilization, controled ovarian stimulation, number of mature oocytes
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSHDrug
Also called Puregon®, Organon Ltd., Irlanda
the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and antral follicle count (AFC). This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days
HMGDrug
Also called Menopur
the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and AFC. This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days
| Study group | Role | What they receive |
|---|---|---|
| drug to ovulation induction: rFSH | Other | Patients submitted to IVF that will use rFSH (Puregon®, Organon Ltd., Ireland) for ovarian stimulation Receives: Drug: rFSH |
| drug to ovulation induction :HMG | Other | Patients submitted to IVF that will use hMG (Menopur®, Ferring Pharmaceuticals, Denmark) for ovarian stimulation Receives: Drug: HMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)
The embryo evaluation will be performed on day three after fertilization based on the Graduated Embryo Score (GES). It will be performed three evaluations occurring at 16 - 18 hours, 25 - 27 hours and 64 - 67 hours post insemination, by the same embryologist (DS) The score is composed by the following criteria: nucleolar alignment along pronuclear axis, regular cleavage and degree of fragmentation at the first cell division, and cell number and morphology on day 3 after fertilization. The score ranges from 20 to 100 per embryo.
Measured: 3 to 5 days after the ovarian punction
Secondary outcomes (4)
number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm
Measured: 10 to 13 days after the IVF protocol starts
total number of units of gonadotrophins used to ovarian stimulation
Measured: 10 to 13 days after the IVF protocol starts
number of oocytes retrieved (MII)
Measured: 10 to 13 days after the IVF protocol starts
number of embryos
Measured: 3 to 5 days after the ovarian punction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Human Reproduction
- Responsible party
- Sponsor
- Investigators
- João SL Cunha Filho, Dr, Principal investigator, Centro de Reproduçao Humana Insemine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412904
- Sponsor's protocol ID
- 130120
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2013
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
- ClinicalTrials.gov ID
- NCT02412904
- Acronym / sponsor ID
- 130120
- Conditions
- Infertility
- Keywords
- follicular stimulating hormone, human menopausal gonadotrophin, Recombinant follicular stimulating hormone (rFSH), Gonadotrophin releasing hormone (GnRH) antagonists, GnRH agonist, in vitro fertilization, controled ovarian stimulation, number of mature oocytes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Center for Human Reproduction
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 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.
rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.
The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.
Detailed description
To compare embryonic quality and other clinical outcomes when using human menopause gonadotropin (hMG) or recombinant follicle stimulating hormone (rFSH) to the ovarian stimulation in IVF cycles with the GnRH antagonist protocol.
Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.
Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.
Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.
Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug to ovulation induction: rFSH | Other | Drug: rFSHPatients submitted to IVF that will use rFSH (Puregon®, Organon Ltd., Ireland) for ovarian stimulation |
| drug to ovulation induction :HMG | Other | Drug: HMGPatients submitted to IVF that will use hMG (Menopur®, Ferring Pharmaceuticals, Denmark) for ovarian stimulation |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 25 to 40 y
- infertile
- submitted to IVF
- no hormonal disease
- normal FSH (< 10)
Key exclusion criteria (5 listed)
- thyroid-stimulating hormone (TSH), prolactin (PRL) altered
- endometrioma
- ovarian tumor or cysts
- previous Ovarian Hyperstimulation Syndrome (OHSS)
- severe male factor
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 |
|---|---|---|
| rFSHAlso: Puregon®, Organon Ltd., Irlandathe patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and antral follicle count (AFC). This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days | Drug | drug to ovulation induction: rFSH |
| HMGAlso: Menopurthe patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and AFC. This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days | Drug | drug to ovulation induction :HMG |
Primary outcome
Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)
Time frame: 3 to 5 days after the ovarian punction
The embryo evaluation will be performed on day three after fertilization based on the Graduated Embryo Score (GES). It will be performed three evaluations occurring at 16 - 18 hours, 25 - 27 hours and 64 - 67 hours post insemination, by the same embryologist (DS) The score is composed by the following criteria: nucleolar alignment along pronuclear axis, regular cleavage and degree of fragmentation at the first cell division, and cell number and morphology on day 3 after fertilization. The score ranges from 20 to 100 per embryo.
4 secondary outcomes
number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm
Time frame: 10 to 13 days after the IVF protocol starts
total number of units of gonadotrophins used to ovarian stimulation
Time frame: 10 to 13 days after the IVF protocol starts
number of oocytes retrieved (MII)
Time frame: 10 to 13 days after the IVF protocol starts
number of embryos
Time frame: 3 to 5 days after the ovarian punction
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 21 Aug 2015.
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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.
João SL Cunha Filho, Dr principal investigator
Centro de Reproduçao Humana Insemine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rFSH and HMG in people with Infertility, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 8 inclusion and 5 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 21 Aug 2015. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES) (time frame: 3 to 5 days after the ovarian punction). 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 21 Aug 2015; AzTrials last refreshed its copy on 27 Oct 2026.