InfertilityNCT02915900
Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
A study testing Gonadotropin removal test and Routine IVF method in people with Infertility, run by Oslo University Hospital at 1 site in Norway.
Trial summary
During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Gonadotropin removal test and Routine IVF method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Jul 2017
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
- Pre-selected starting dose <110 IU or >270 IU FSH
Who cannot join
- Risk for hyperstimulation
- Polycystic ovary syndrome
- Endometriosis stage >III
- BMI>33
- Anti-mullerian hormone value missing
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Reproductive Medicine, Oslo University Hospital
Oslo
About this study
Official title: Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.
Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.
Read more
In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.
The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.
- Conditions
- Infertility
- Being tested
- Gonadotropin removal test, Routine IVF method
- Keywords
- In vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin removal testOther
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Routine IVF methodOther
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Hormone dosage is calculated by using the new method Gonadotropin removal test. Receives: Other: Gonadotropin removal test |
| Routine IVF method | Active comparator | Hormone dosage is chosen by the clinician according to standard clinical routine. Receives: Other: Routine IVF method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. The mean these differences is compared between treatment and control groups.
Measured: The day of follicle aspiration.
Consistency of optimal ovarian response during stimulation.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. Variance of these differences is compared between treatment and control groups.
Measured: The day of follicle aspiration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionJul 2017
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 Oslo University HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Zoltan Fedorcsak, Oslo University Hospital
- Investigators
- Peter Fedorcsak, MD, PhD, Principal investigator, OUS-HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915900
- Sponsor's protocol ID
- 233978
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data might be shared with patient if requested
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT02915900
- Acronym / sponsor ID
- 233978
- Conditions
- Infertility
- Keywords
- In vitro fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Sep 2016 (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.
During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.
Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.
In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.
The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Gonadotropin removal testHormone dosage is calculated by using the new method Gonadotropin removal test. |
| Routine IVF method | Active comparator | Other: Routine IVF methodHormone dosage is chosen by the clinician according to standard clinical routine. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
- Pre-selected starting dose <110 IU or >270 IU FSH
Key exclusion criteria (5 listed)
- Risk for hyperstimulation
- Polycystic ovary syndrome
- Endometriosis stage >III
- BMI>33
- Anti-mullerian hormone value missing
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 |
|---|---|---|
| Gonadotropin removal testPatient receives hormone dosage adjusted according to the results of the Gonadotropin removal test. | Other | Intervention |
| Routine IVF methodPatient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician. | Other | Routine IVF method |
Primary outcome
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
Time frame: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. The mean these differences is compared between treatment and control groups.
Consistency of optimal ovarian response during stimulation.
Time frame: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. Variance of these differences is compared between treatment and control groups.
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 19 Sep 2017.
- patentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data might be shared with patient if requested
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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.
Peter Fedorcsak, MD, PhD principal investigator
OUS-HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin removal test and Routine IVF method in people with Infertility, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 5 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 19 Sep 2017. 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 Norway. 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?
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration (time frame: The day of follicle aspiration.). The study lists 2 primary outcomes in all. 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 19 Sep 2017.