InfertilityPhase 3NCT00948805
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
A Phase 3 study testing GnRH agonist in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- GnRH agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 3
- 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 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age >21 and < 38 years old
- polycystic ovarian syndrome
- risk for ovarian hyperstimulation syndrome
Who cannot join
- recurrent abortion
- endometriosis
- more than 3 IVF failures
- use of oral contraceptive pills in the preceding 3 months
- low response to gonadotropins
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo
São Paulo, São Paulo, 05403000
Cláudia Gomes, MD, 551176569373, cgomes@huntington.com.br
Cláudia Gomes, MD
About this study
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.
Read the detailed description
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.
- Conditions
- Infertility
- Being tested
- GnRH agonist, Control
- Keywords
- corpus luteum rescue, Gonadotropin Releasing Hormone (GnRH agonist), human Chorionic Gonadotropin (hCG), infertility, pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
Also called Ovidrel, Zoladex, Gonal
3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation
ControlDrug
Also called Zoladex, Ovidrel, Gonal
250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist | Experimental | 3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. Receives: Drug: GnRH agonist |
| Control | Active comparator | 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of functional rescue of corpus luteum
Measured: 6 months
Secondary outcomes (3)
Pregnancy rate
Measured: 6 months
Levels of serum steroids
Measured: 6 months
Levels of serum gonadotropins
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionJul 2010 (estimated)
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Paulo Serafini, PhD, Study chair, Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948805
- Sponsor's protocol ID
- 0555/09
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT00948805
- Acronym / sponsor ID
- 0555/09
- Conditions
- Infertility
- Keywords
- corpus luteum rescue, Gonadotropin Releasing Hormone (GnRH agonist), human Chorionic Gonadotropin (hCG), infertility, pregnancy rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 29 Jul 2009 (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.
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.
Detailed description
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist | Experimental | Drug: GnRH agonist3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. |
| Control | Active comparator | Drug: Control250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age >21 and < 38 years old
- polycystic ovarian syndrome
- risk for ovarian hyperstimulation syndrome
Key exclusion criteria (5 listed)
- recurrent abortion
- endometriosis
- more than 3 IVF failures
- use of oral contraceptive pills in the preceding 3 months
- low response to gonadotropins
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 |
|---|---|---|
| GnRH agonistAlso: Ovidrel, Zoladex, Gonal3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation | Drug | GnRH agonist |
| ControlAlso: Zoladex, Ovidrel, Gonal250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation | Drug | Control |
Primary outcome
Frequency of functional rescue of corpus luteum
Time frame: 6 months
3 secondary outcomes
Pregnancy rate
Time frame: 6 months
Levels of serum steroids
Time frame: 6 months
Levels of serum gonadotropins
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
- University of São Paulo web pageLink provided by the sponsor.
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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.
Paulo Serafini, PhD study chair
Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GnRH agonist in people with Infertility, run by University of Sao Paulo 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 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cláudia M Gomes, MD (551130596122, cgomes@huntington.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of functional rescue of corpus luteum (time frame: 6 months). 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 29 Jul 2009.