Infertility, SubfertilityNCT01206803
Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients
An observational study of Infertility, Subfertility, run by University Hospital Schleswig-Holstein at 5 sites in 2 countries.
Trial summary
The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH), demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of gonadotropin receptors and secreted… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Subfertility
- What is being tested?
- Ovarian stimulation in a GnRH-antagonist protocol
- How many people
- 294 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2010to Jan 2014
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with an indication for IVF or ICSI
Who may be able to join
- Female patients for who the treating physician decides that treatment with long acting FSH 150µg in a GnRH-antagonist protocol is indicated.
Who cannot join
- Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal preparations within one month prior to inclusion
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Fertility Center Kiel
Kiel, S-H, 24103
University Hospital of Schleswig-Holstein, Campus Luebeck
Lübeck, Schleswig-Holstein, 23538
Prof. Axel Kamischke
Münster, 48143
Sabine Segerer
Würzburg, 97080
About this study
Official title: Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol
The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH), demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of gonadotropin receptors and secreted gonadotropins).
Read the detailed description
Assisted reproduction by in-vitro fertilisation plays a pivotal role in the treatment of infertility, the understanding of reproductive biology, and future population dynamics. The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation which aim at providing an adequate number of good quality oocytes for in-vitro laboratory procedures. Interindividual variation in response to follicle-stimulating hormone (FSH) is a widespread problem with clinical and economical implications. A group of patients (9%-24%) tend to respond poorly to controlled ovarian stimulation (COS) whereas other patients tend to overrespond (2.5%) and thus run at risk of developing ovarian hyperstimulation syndrome, a potentially life-threatening disease. Polymorphisms of gonadotropin receptors seem to have an influence on the outcome of controlled ovarian hyperstimulation treatment, e.g. contributing to the variation in ovarian response to exogenous FSH between individuals. Other predictive factors include demographic (age), sonographic (follicular count in the ovaries, ovarian volume), endocrine (serum gonadotropin levels and Anti-Muellerian Hormone) and life-style factors (smoking, obesity). Such factors are routinely obtained prior to a treatment cycle, and are used to determine the optimal FSH starting dose or the best treatment regimen. The identification of gonadotropin receptor polymorphisms and variants in secreted gonadotropins prior to an ovarian stimulation treatment should allow the clinicians to tailor the starting dose of rFSH, especially for patients undergoing their first treatment cycle, as such ovarian response prediction will prevent cycle cancellations due to too low or too high ovarian response and reduce the risk of OHSS. The aim of the present study is to identify the prevalence of FSH and LH receptor polymorphisms and hormonal variants of LH and to study the variation attributable to these genetics factors when controlling for already established predictors of ovarian response to exogenous FSH in a multi-variate analysis.
- Conditions
- Infertility, Subfertility
- Being tested
- Ovarian stimulation in a GnRH-antagonist protocol
- Keywords
- ovarian stimulation, recombinant FSH, GnRH-antagonist, corifollitropin alfa
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian stimulation in a GnRH-antagonist protocolDrug
Also called Elonva, Puregon, Orgalutran, Predalon, Crinone
Long-acting FSH 150µg \& daily recombinant FSH 200 IU, GnRH-antagonist 0.25mg, 5,000-10,000 IU urinary hCG, triptorelin 0.2mg, vaginal progesterone
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cumulus-oocyte-complexes
the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation
Measured: at the time of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, SubfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Griesinger, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206803
- Sponsor's protocol ID
- GR 3422/3-1
- Status last verified
- Jan 2016
- First submitted
- 21 Sep 2010
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol
- ClinicalTrials.gov ID
- NCT01206803
- Acronym / sponsor ID
- GR 3422/3-1
- Conditions
- Infertility, Subfertility
- Keywords
- ovarian stimulation, recombinant FSH, GnRH-antagonist, corifollitropin alfa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Sep 2010 (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 aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH), demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of gonadotropin receptors and secreted gonadotropins).
Detailed description
Assisted reproduction by in-vitro fertilisation plays a pivotal role in the treatment of infertility, the understanding of reproductive biology, and future population dynamics. The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation which aim at providing an adequate number of good quality oocytes for in-vitro laboratory procedures. Interindividual variation in response to follicle-stimulating hormone (FSH) is a widespread problem with clinical and economical implications. A group of patients (9%-24%) tend to respond poorly to controlled ovarian stimulation (COS) whereas other patients tend to overrespond (2.5%) and thus run at risk of developing ovarian hyperstimulation syndrome, a potentially life-threatening disease. Polymorphisms of gonadotropin receptors seem to have an influence on the outcome of controlled ovarian hyperstimulation treatment, e.g. contributing to the variation in ovarian response to exogenous FSH between individuals. Other predictive factors include demographic (age), sonographic (follicular count in the ovaries, ovarian volume), endocrine (serum gonadotropin levels and Anti-Muellerian Hormone) and life-style factors (smoking, obesity). Such factors are routinely obtained prior to a treatment cycle, and are used to determine the optimal FSH starting dose or the best treatment regimen. The identification of gonadotropin receptor polymorphisms and variants in secreted gonadotropins prior to an ovarian stimulation treatment should allow the clinicians to tailor the starting dose of rFSH, especially for patients undergoing their first treatment cycle, as such ovarian response prediction will prevent cycle cancellations due to too low or too high ovarian response and reduce the risk of OHSS. The aim of the present study is to identify the prevalence of FSH and LH receptor polymorphisms and hormonal variants of LH and to study the variation attributable to these genetics factors when controlling for already established predictors of ovarian response to exogenous FSH in a multi-variate analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients with an indication for IVF or ICSI
Key inclusion criteria (1 listed)
- Female patients for who the treating physician decides that treatment with long acting FSH 150µg in a GnRH-antagonist protocol is indicated.
Key exclusion criteria (1 listed)
- Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal preparations within one month prior to inclusion
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 |
|---|---|---|
| Ovarian stimulation in a GnRH-antagonist protocolAlso: Elonva, Puregon, Orgalutran, Predalon, CrinoneLong-acting FSH 150µg \& daily recombinant FSH 200 IU, GnRH-antagonist 0.25mg, 5,000-10,000 IU urinary hCG, triptorelin 0.2mg, vaginal progesterone | Drug | – |
Primary outcome
number of cumulus-oocyte-complexes
Time frame: at the time of oocyte retrieval
the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation
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 5 Jan 2016.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Subfertility, run by University Hospital Schleswig-Holstein at 5 sites in 2 countries.
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 1 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 5 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 5 sites in Germany, 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?
number of cumulus-oocyte-complexes (time frame: at the time of oocyte retrieval). 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 5 Jan 2016.