Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Infertility, Subfertility |
Drug: Ovarian stimulation in a GnRH-antagonist protocol |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol |
- number of cumulus-oocyte-complexes [ Time Frame: at the time of oocyte retrieval ] [ Designated as safety issue: No ]the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation
Biospecimen Retention: Samples With DNA
Serum samples for analysis of gonadotropins and Anti-Muellerian Hormone EDTA samples for DNA extraction
| Estimated Enrollment: | 240 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
-
Drug: Ovarian stimulation in a GnRH-antagonist protocol
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Female patients with an indication for IVF or ICSI
Inclusion Criteria:
Female patients for who the treating physician decides that treatment with long acting FSH 150µg in a GnRH-antagonist protocol is indicated.
Exclusion Criteria:
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
Contacts and Locations| Contact: Georg Griesinger, Prof. Dr. M.Sc. | +49 451 500 ext 4418 | griesing@uni-luebeck.de |
| Contact: Askan Schultze-Mosgau, MD | +49 451 500 ext 4418 | a.schultze-mosgau@web.de |
| Austria | |
| Das Kinderwunsch Institut, Schenk GmbH | Recruiting |
| Dobl, Austria, 8143 | |
| Contact: Michael Schenk, MD 0043-(0)3136-55111 m.schenk@kinderwunsch-institut.at | |
| Principal Investigator: Michael Schenk, MD | |
| Germany | |
| Fertility Center Kiel | Recruiting |
| Kiel, S-H, Germany, 24103 | |
| Contact: Soeren von Otte, MD 0431 97413 ext 0 svonotte@gmx.de | |
| Principal Investigator: Sören von Otte, MD | |
| University Hospital of Schleswig-Holstein, Campus Luebeck | Recruiting |
| Luebeck, Schleswig-Holstein, Germany, 23538 | |
| Contact: Georg Griesinger, Prof. Dr. +49 451 500 ext 4418 griesing@uni-luebeck.de | |
| Principal Investigator: Georg Griesinger, MD MSc | |
| Sub-Investigator: Askan Schultze-Mosgau, MD | |
| Sub-Investigator: Tim Cordes, MD | |
| Sub-Investigator: Nana Bündgen, MD | |
| Kinderwunschzentrum Dortmund | Recruiting |
| Dortmund, Germany, 44135 | |
| Contact: Stefan Dieterle, MD (+49) 231 5575450 dieterle@ivf-dortmund.de | |
| Principal Investigator: Stefan Dieterle, MD | |
| Sub-Investigator: Robert Greb, MD | |
| Sub-Investigator: Andreas Neuer, MD | |
| Prof. Axel Kamischke | Recruiting |
| Münster, Germany, 48143 | |
| Contact: Axel Kamischke, MD +49 251-48267-0 a.kamischke@ivf-muenster.de | |
| Principal Investigator: Axel Kamischke, MD | |
| Torsten Frambach | Recruiting |
| Würzburg, Germany, 97080 | |
| Contact: Torsten Frambach, MD +49 (0931) 201-25621 Frambach_T@klinik.uni-wuerzburg.de | |
| Principal Investigator: Torsten Frambach, MD | |
More Information
No publications provided
| Responsible Party: | Georg Griesinger, Prof. Dr., University of Luebeck |
| ClinicalTrials.gov Identifier: | NCT01206803 History of Changes |
| Other Study ID Numbers: | GR 3422/3-1 |
| Study First Received: | September 21, 2010 |
| Last Updated: | December 7, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Schleswig-Holstein:
|
ovarian stimulation, recombinant FSH, GnRH-antagonist, corifollitropin alfa |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013