InfertilityNCT00485537
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
A study testing oocyte retrieval and ICSI procedure in people with Infertility, run by Clinic and Research Center in Human Reproduction Roger Abdelmassih at 1 site in Brazil.
Trial summary
Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- oocyte retrieval and ICSI procedure
- Type of treatment
- Surgery or procedure
- How many people
- 2,005 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2005to Dec 2006
- 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 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels < 12 IU/l, basal levels of estradiol < 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound
Who cannot join
- use of exogenous LH during stimulation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinica e Centro de Reprodução Humana Roger Abdelmassih
São Paulo, São Paulo, 01431-000
About this study
Official title: Pregnancy Outcomes With a Gonadotropin-Releasing Hormone (GnRH) Antagonist (Cetrorelix) Protocol Versus GnRH-Agonist Protocol in Ovarian Stimulation for ICSI Cycles-a Prospective Study
Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.
Read the detailed description
160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.
- Conditions
- Infertility
- Being tested
- oocyte retrieval and ICSI procedure
- Keywords
- GnRH antagonist, GnRH agonist, ICSI, miscarriage rate, pregnancy outcome
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oocyte retrieval and ICSI procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative response to ICSI cycles with GnRH agosnist and cetrotide
Measured: 16 months
Secondary outcomes (1)
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startSep 2005
- Study completionDec 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic and Research Center in Human Reproduction Roger Abdelmassih
- Sponsor type
- University, hospital or other
- Investigators
- Rosa M Neme, MD,PhD, Principal investigator, Clinic and Research Center in Human Reproduction Roger Abdelmassih
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485537
- Sponsor's protocol ID
- RA0001
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes With a Gonadotropin-Releasing Hormone (GnRH) Antagonist (Cetrorelix) Protocol Versus GnRH-Agonist Protocol in Ovarian Stimulation for ICSI Cycles-a Prospective Study
- ClinicalTrials.gov ID
- NCT00485537
- Acronym / sponsor ID
- RA0001
- Conditions
- Infertility
- Keywords
- GnRH antagonist, GnRH agonist, ICSI, miscarriage rate, pregnancy outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,005 participants (actual)
- Lead sponsor
- Clinic and Research Center in Human Reproduction Roger AbdelmassihUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Jun 2007 (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.
Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.
Detailed description
160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels < 12 IU/l, basal levels of estradiol < 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound
Key exclusion criteria (1 listed)
- use of exogenous LH during stimulation
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 |
|---|---|---|
| oocyte retrieval and ICSI procedure | Procedure or surgery | – |
Primary outcome
Comparative response to ICSI cycles with GnRH agosnist and cetrotide
Time frame: 16 months
1 secondary outcome
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
Time frame: 16 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 Jun 2007.
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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.
Rosa M Neme, MD,PhD principal investigator
Clinic and Research Center in Human Reproduction Roger Abdelmassih
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oocyte retrieval and ICSI procedure in people with Infertility, run by Clinic and Research Center in Human Reproduction Roger Abdelmassih 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 1 inclusion and 1 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 Jun 2007. 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?
Comparative response to ICSI cycles with GnRH agosnist and cetrotide (time frame: 16 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 13 Jun 2007.