InfertilityPhase 4LHNCT02108223
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
A Phase 4 study testing fix dose r-FSH (Gonal-f), r-LH supplementation and r-FSH (Gonal-f) in people with Infertility, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. Read more about this study
- Who is it for?
- Ages 23 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- fix dose r-FSH (Gonal-f), r-LH supplementation and r-FSH (Gonal-f)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 23 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 23-39
- Body mass index between 18 and 30 kg/m2
- Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
- The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
- Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
- Who were having their first or second IVF trial.
Who cannot join
- Grade III-IV endometriosis
- Clinically significant condition preventing them from undergoing gonadotrophin treatment
- More than two previous assisted cycles
- Who had a single ovary
- Unexplained gynaecological bleeding
- Polycystic ovary or an ovarian cyst of unknown aetiology
- Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity
- Have a chromosomal anomaly.
About this study
Official title: In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Read the detailed description
- Aim -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
- Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.
- Conditions
- Infertility
- Being tested
- fix dose r-FSH (Gonal-f), r-LH supplementation, r-FSH (Gonal-f)
- Keywords
- ICSI, Suboptimal Ovarian Response, rLH
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fix dose r-FSH (Gonal-f)Drug
Also called puregon
recombinant follicle stimulation
r-LH supplementationDrug
Also called luveris
recombinant luteinizing hormone
r-FSH (Gonal-f)Drug
Also called puregon
recombinant follicle stimulation hormone
| Study group | Role | What they receive |
|---|---|---|
| fix dose r-FSH (Gonal-f) | Active comparator | The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 Receives: Drug: fix dose r-FSH (Gonal-f) |
| r-LH supplementation to r-FSH | Active comparator | On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. Receives: Drug: r-LH supplementation |
| r-FSH (Gonal-f) | Active comparator | Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. Receives: Drug: r-FSH (Gonal-f) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
Measured: Up to 9 month
Secondary outcomes (4)
the Number of Oocytes Retrieved
median number of oocytes retrieved per participant
Measured: up to 9 month
Number of Mature Oocyte
median number of mature oocytes retrieved per participant
Measured: up to 9 month
Fertilization Rate
fertilization rate used to measure how many oocytes become fertilized by sperm cells
Measured: up to 9 month
Implantation Rates
Implantation rate is the percentage of embryos which successfully undergo implantation
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Principal investigator, fatma yazıcı yılmaz, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- fatma yazıcı yılmaz, MD, Principal investigator, Sisli Etfal training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108223
- Sponsor's protocol ID
- 4085
- Acronym
- LH
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2014
- Last updated
- 20 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.
- ClinicalTrials.gov ID
- NCT02108223
- Acronym / sponsor ID
- LH / 4085
- Conditions
- Infertility
- Keywords
- ICSI, Suboptimal Ovarian Response, rLH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Detailed description
- Aim -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
- Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fix dose r-FSH (Gonal-f) | Active comparator | Drug: fix dose r-FSH (Gonal-f)The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 |
| r-LH supplementation to r-FSH | Active comparator | Drug: r-LH supplementationOn day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. |
| r-FSH (Gonal-f) | Active comparator | Drug: r-FSH (Gonal-f)Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. |
Who may qualify
- Ages
- 23 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 23-39
- Body mass index between 18 and 30 kg/m2
- Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
- The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
- Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
Key exclusion criteria (8 listed)
- Grade III-IV endometriosis
- Clinically significant condition preventing them from undergoing gonadotrophin treatment
- More than two previous assisted cycles
- Who had a single ovary
- Unexplained gynaecological bleeding
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 |
|---|---|---|
| fix dose r-FSH (Gonal-f)Also: puregonrecombinant follicle stimulation | Drug | fix dose r-FSH (Gonal-f) |
| r-LH supplementationAlso: luverisrecombinant luteinizing hormone | Drug | r-LH supplementation to r-FSH |
| r-FSH (Gonal-f)Also: puregonrecombinant follicle stimulation hormone | Drug | r-FSH (Gonal-f) |
Primary outcome
Pregnancy Rate
Time frame: Up to 9 month
percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
4 secondary outcomes
the Number of Oocytes Retrieved
Time frame: up to 9 month
Number of Mature Oocyte
Time frame: up to 9 month
Fertilization Rate
Time frame: up to 9 month
Implantation Rates
Time frame: up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
fatma yazıcı yılmaz, MD principal investigator
Sisli Etfal training and research hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fix dose r-FSH (Gonal-f), r-LH supplementation and r-FSH (Gonal-f) in people with Infertility, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 6 inclusion and 8 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pregnancy Rate (time frame: Up to 9 month). 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 Mar 2015.