InfertilityGonapeptylNCT01468441
Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
A study testing Triptorelin and Cetrorelix in people with Infertility, run by Fertility - Assisted Fertilization Center at 1 site in Brazil.
Trial summary
The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating… Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Triptorelin and Cetrorelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Mar 2012
- Phase
- Interventional
- 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 Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women of good physical and mental health
- under 37 years old, with regular menstrual cycles of 25-35 days
- normal basal FSH and LH levels
- BMI less than 30 kg/m2
- presence of both ovaries and intact uterus
- absence of polycystic ovaries
Show all 9Show fewer
- endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
- all patients signed a written informed consent form
- no patient had received any hormone therapy for at least 60 days preceding the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fertility - Assisted Fertilization Center
São Paulo, São Paulo, 01401-002
About this study
Official title: Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.
Read the detailed description
Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.
No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.
- Conditions
- Infertility
- Being tested
- Triptorelin, Cetrorelix
- Keywords
- ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptorelinDrug
Also called Gonapeptyl
Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.
CetrorelixDrug
Also called Cetrotide
When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist | Experimental | Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation. Receives: Drug: Triptorelin |
| GnRH antagonist | Active comparator | Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation. Receives: Drug: Cetrorelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of treatment
Measured: One month
Secondary outcomes (1)
Implantation and pregnancy rates
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertility - Assisted Fertilization Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luiz Guilherme Maldonado, M.Sc., Principal investigator, Fertility - Assisted Fertilization Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468441
- Sponsor's protocol ID
- Fert-LG-Doutorado
- Acronym
- Gonapeptyl
- Status last verified
- Jul 2012
- First submitted
- 31 Oct 2011
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maldonado LG, Franco JG Jr, Setti AS, Iaconelli A Jr, Borges E Jr. Cost-effectiveness comparison between pituitary down-regulation with a gonadotropin-releasing hormone agonist short regimen on alternate days and an antagonist protocol for assisted fertilization treatments. Fertil Steril. 2013 May;99(6):1615-22. doi: 10.1016/j.fertnstert.2013.01.095. Epub 2013 Feb 5.
PubMed 23394779
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
- ClinicalTrials.gov ID
- NCT01468441
- Acronym / sponsor ID
- Gonapeptyl / Fert-LG-Doutorado
- Conditions
- Infertility
- Keywords
- ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fertility - Assisted Fertilization CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Nov 2011 (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 present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.
Detailed description
Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.
No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist | Experimental | Drug: TriptorelinAdministration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation. |
| GnRH antagonist | Active comparator | Drug: CetrorelixDaily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- women of good physical and mental health
- under 37 years old, with regular menstrual cycles of 25-35 days
- normal basal FSH and LH levels
- BMI less than 30 kg/m2
- presence of both ovaries and intact uterus
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TriptorelinAlso: GonapeptylTriptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration. | Drug | GnRH agonist |
| CetrorelixAlso: CetrotideWhen patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration. | Drug | GnRH antagonist |
Primary outcome
cost of treatment
Time frame: One month
1 secondary outcome
Implantation and pregnancy rates
Time frame: 2 months
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 13 Jul 2012.
- Derived from this study: PubMed 23394779Maldonado LG, Franco JG Jr, Setti AS, Iaconelli A Jr, Borges E Jr. Cost-effectiveness comparison between pituitary down-regulation with a gonadotropin-releasing hormone agonist short regimen on alternate days and an antagonist protocol for assisted fertilization treatments. Fertil Steril. 2013 May;99(6):1615-22. doi: 10.1016/j.fertnstert.2013.01.095. Epub 2013 Feb 5.
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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.
Luiz Guilherme Maldonado, M.Sc. principal investigator
Fertility - Assisted Fertilization Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triptorelin and Cetrorelix in people with Infertility, run by Fertility - Assisted Fertilization Center 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 9 inclusion and 0 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 13 Jul 2012. 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.
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?
cost of treatment (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468441, which also lists 1 linked publication.
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 13 Jul 2012.