InfertilityNCT02293668
Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients
A study testing FSH 225IU and hMG 225IU, FSH 150IU and hMG 150IU and Letrozole 5mg and hMG 150IU in people with Infertility, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- FSH 225IU and hMG 225IU, FSH 150IU and hMG 150IU and Letrozole 5mg and hMG 150IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 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
Istanbul University School of Medicine
Istanbul, 34093
About this study
There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.
- Conditions
- Infertility
- Being tested
- FSH 225IU and hMG 225IU, FSH 150IU and hMG 150IU, Letrozole 5mg and hMG 150IU
- Keywords
- poor responders
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH 225IU and hMG 225IUDrug
FSH 150IU and hMG 150IUDrug
Letrozole 5mg and hMG 150IUDrug
| Study group | Role | What they receive |
|---|---|---|
| Combined 450 | Active comparator | Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. Receives: Drug: FSH 225IU and hMG 225IU |
| Combined 300 | Active comparator | Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. Receives: Drug: FSH 150IU and hMG 150IU |
| Letrozole and hMG | Active comparator | Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/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: Letrozole 5mg and hMG 150IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 8 weeks
Secondary outcomes (3)
Number of oocytes retrieved
Measured: 4 weeks
Number of transferable embryos
Measured: 4 weeks
Biochemical pregnancy rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 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 InfertilityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercan Bastu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293668
- Sponsor's protocol ID
- 1001
- Status last verified
- Jan 2016
- First submitted
- 14 Nov 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
- Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients
- ClinicalTrials.gov ID
- NCT02293668
- Acronym / sponsor ID
- 1001
- Conditions
- Infertility
- Keywords
- poor responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Nov 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.
There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined 450 | Active comparator | Drug: FSH 225IU and hMG 225IURecombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
| Combined 300 | Active comparator | Drug: FSH 150IU and hMG 150IURecombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
| Letrozole and hMG | Active comparator | Drug: Letrozole 5mg and hMG 150IULetrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/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. |
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 |
|---|---|---|
| FSH 225IU and hMG 225IU | Drug | Combined 450 |
| FSH 150IU and hMG 150IU | Drug | Combined 300 |
| Letrozole 5mg and hMG 150IU | Drug | Letrozole and hMG |
Primary outcome
Clinical pregnancy rate
Time frame: 8 weeks
3 secondary outcomes
Number of oocytes retrieved
Time frame: 4 weeks
Number of transferable embryos
Time frame: 4 weeks
Biochemical pregnancy rate
Time frame: 6 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSH 225IU and hMG 225IU, FSH 150IU and hMG 150IU and Letrozole 5mg and hMG 150IU in people with Infertility, run by Istanbul University 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?
Clinical pregnancy rate (time frame: 8 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 NCT02293668, 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.