Polycystic Ovarian SyndromeNCT00894608
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
A study testing letrozole + gonadotropins and GnRHa + gonadotropins in people with Polycystic Ovarian Syndrome, run by Yunyang Medical College at 1 site in China.
Trial summary
The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- letrozole + gonadotropins and GnRHa + gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with PCOS
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS
The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.
Read the detailed description
Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. A significant proportion of these women will ultimately need assisted reproductive techniques. Various protocols of ovarian stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed for optimizing IVF results in patients with PCOS. The results of these studies have shown it not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH and reduced gonadotrophin dose required for COH without having a negative impact on pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- letrozole + gonadotropins, GnRHa + gonadotropins
- Keywords
- letrozole, ovarian stimulation, PCOS, IVF-ET
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozole + gonadotropinsDrug
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
GnRHa + gonadotropinsDrug
patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins
| Study group | Role | What they receive |
|---|---|---|
| letrozole protocol | Experimental | patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins Receives: Drug: letrozole + gonadotropins |
| long GnRHa protocol | Experimental | patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins Receives: Drug: GnRHa + gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunyang Medical College
- Sponsor type
- University, hospital or other
- Investigators
- zhang changjun, doctor, Study director, renmin hospital,yunyang medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894608
- Sponsor's protocol ID
- a00949200
- Status last verified
- May 2009
- First submitted
- 5 May 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS
- ClinicalTrials.gov ID
- NCT00894608
- Acronym / sponsor ID
- a00949200
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- letrozole, ovarian stimulation, PCOS, IVF-ET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yunyang Medical CollegeUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 May 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.
The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.
Detailed description
Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. A significant proportion of these women will ultimately need assisted reproductive techniques. Various protocols of ovarian stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed for optimizing IVF results in patients with PCOS. The results of these studies have shown it not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH and reduced gonadotrophin dose required for COH without having a negative impact on pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole protocol | Experimental | Drug: letrozole + gonadotropinspatients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins |
| long GnRHa protocol | Experimental | Drug: GnRHa + gonadotropinspatients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with PCOS
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 |
|---|---|---|
| letrozole + gonadotropinspatients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins | Drug | letrozole protocol |
| GnRHa + gonadotropinspatients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins | Drug | long GnRHa protocol |
Primary outcome
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
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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.
zhang changjun, doctor study director
renmin hospital,yunyang medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing letrozole + gonadotropins and GnRHa + gonadotropins in people with Polycystic Ovarian Syndrome, run by Yunyang Medical College at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 7 May 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 China. 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?
Results are not available in the source record.
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?
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate (time frame: 2 years). 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 7 May 2009.