Poor RespondersNCT02158689
Comparison of Treatment Modalities in Poor Responders Undergoing IVF
A study testing Letrozole and human menopausal gonadotropin (hMG) in people with Poor Responders, run by Ercan Bastu at 1 site in Turkey (Türkiye).
Trial summary
The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Poor Responders
- What is being tested?
- Letrozole and human menopausal gonadotropin (hMG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Aug 2015
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
- Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
- advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
- a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
- an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Obstetrics and Gynecology, Istanbul University School of Medicine
Istanbul, 34093
About this study
The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.
- Conditions
- Poor Responders
- Being tested
- Letrozole, human menopausal gonadotropin (hMG)
- Keywords
- Poor responders, letrozole, human menopausal gonadotropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
human menopausal gonadotropin (hMG)Drug
| Study group | Role | What they receive |
|---|---|---|
| human menopausal gonadotropin (hMG) | Active comparator | hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. Receives: Drug: human menopausal gonadotropin (hMG) |
| Letrozole | Active comparator | Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle.
Measured: up to 2 weeks
Secondary outcomes (5)
Cancellation Rate
One of the secondary outcome measures will be cancellation rate.
Measured: up to one month
Number of oocytes retrieved
One of the secondary outcome measures will be number of oocytes retrieved.
Measured: up to one month
Number of transferable embryos
One of the secondary outcome measures will be number of transferable embryos.
Measured: up to one month
Implantation rate
One of the secondary outcome measures will be implantation rates.
Measured: up to 2 weeks
Clinical pregnancy rate
One of the secondary outcome measures will be clinical pregnancy rates.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionAug 2015
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 Poor RespondersStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ercan Bastu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ercan Bastu, Istanbul University
- Investigators
- Harika Yumru, M.D., Principal investigator, Istanbul University School of MedicineHasan F Buyru, M.D. Prof., Study chair, Istanbul University School of MedicineErcan Bastu, M.D., Study director, Istanbul University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158689
- Sponsor's protocol ID
- 10017
- Status last verified
- Jan 2016
- First submitted
- 27 May 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
PubMed 21505041
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Modalities in Poor Responders Undergoing IVF
- ClinicalTrials.gov ID
- NCT02158689
- Acronym / sponsor ID
- 10017
- Conditions
- Poor Responders
- Keywords
- Poor responders, letrozole, human menopausal gonadotropin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ercan BastuUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Jun 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 accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human menopausal gonadotropin (hMG) | Active comparator | Drug: human menopausal gonadotropin (hMG)hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
| Letrozole | Active comparator | Drug: LetrozoleLetrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
- Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
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 |
|---|---|---|
| LetrozoleAlso: Femara | Drug | Letrozole |
| human menopausal gonadotropin (hMG) | Drug | human menopausal gonadotropin (hMG) |
Primary outcome
Ongoing pregnancy rate
Time frame: up to 2 weeks
The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle.
5 secondary outcomes
Cancellation Rate
Time frame: up to one month
Number of oocytes retrieved
Time frame: up to one month
Number of transferable embryos
Time frame: up to one month
Implantation rate
Time frame: up to 2 weeks
Clinical pregnancy rate
Time frame: up to 2 weeks
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 8 Jan 2016.
- Background: PubMed 21505041Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
Related trials for Poor Responders
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
Not yet recruitingPhase 2
Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy
HIV - Human Immunodeficiency Virus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
Obesity & Overweight
Not yet recruitingPhase 1/2
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
Poor Ovarian Reserve, Infertility (IVF Patients)
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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.
Harika Yumru, M.D. principal investigator
Istanbul University School of Medicine
Hasan F Buyru, M.D. Prof. study chair
Istanbul University School of Medicine
Ercan Bastu, M.D. study director
Istanbul University School of Medicine
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 and human menopausal gonadotropin (hMG) in people with Poor Responders, run by Ercan Bastu at 1 site in Turkey (Türkiye).
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 5 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 8 Jan 2016. 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 Turkey (Türkiye). 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?
Ongoing pregnancy rate (time frame: up to 2 weeks). 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 NCT02158689, 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 8 Jan 2016.