InfertilityNCT02128360
Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve
A study testing Letrozole, Gonadotropins and Gonadotropins in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Letrozole, Gonadotropins and Gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Jun 2016
- 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 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of poor responder to ovarian stimulation
Who cannot join
- Patients undergoing pregestational diagnosis (PGD)
- Patients using donor eggs
Trial locations and contacts
1 site in 1 country.
Shir Dar, MD contact
About this study
Official title: Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve
The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.
Read the detailed description
A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.
- Conditions
- Infertility
- Being tested
- Letrozole, Gonadotropins, Gonadotropins
- Keywords
- Low ovarian reserve, Poor responder, Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole, GonadotropinsDrug
GonadotropinsDrug
| Study group | Role | What they receive |
|---|---|---|
| Minimal stimulation protocol | Active comparator | Low dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size Receives: Drug: Letrozole, Gonadotropins |
| High dose protocol | Active comparator | High dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size Receives: Drug: Gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rates
Measured: 1 Year
Secondary outcomes (2)
Number of High quality embryos
How many embryos of 6-8 cells with low fragmentation in each arm
Measured: 1 year
Number of eggs retrieved
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (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 Sheba Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shir Dar, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128360
- Sponsor's protocol ID
- SHEBA-14-1034-SD-CTIL
- Status last verified
- Nov 2014
- First submitted
- 23 Mar 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve
- ClinicalTrials.gov ID
- NCT02128360
- Acronym / sponsor ID
- SHEBA-14-1034-SD-CTIL
- Conditions
- Infertility
- Keywords
- Low ovarian reserve, Poor responder, Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 May 2014 (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 minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.
Detailed description
A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal stimulation protocol | Active comparator | Drug: Letrozole, GonadotropinsLow dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size |
| High dose protocol | Active comparator | Drug: GonadotropinsHigh dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of poor responder to ovarian stimulation
Key exclusion criteria (2 listed)
- Patients undergoing pregestational diagnosis (PGD)
- Patients using donor eggs
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, Gonadotropins | Drug | Minimal stimulation protocol |
| Gonadotropins | Drug | High dose protocol |
Primary outcome
Clinical pregnancy rates
Time frame: 1 Year
2 secondary outcomes
Number of High quality embryos
Time frame: 1 year
Number of eggs retrieved
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Shir Dar, MD contact
Shir Dar, MD principal investigator
Sheba Medical 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 Letrozole, Gonadotropins and Gonadotropins in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
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 2 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 20 Nov 2014. 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 Israel. 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?
Contact Shir Dar, MD (dr.shirdar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rates (time frame: 1 Year). 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 20 Nov 2014.