Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Georg Griesinger, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01206803
First received: September 21, 2010
Last updated: January 4, 2016
Last verified: January 2016
  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

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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

Enrollment: 294
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ovarian stimulation in a GnRH-antagonist protocol
    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
    Other Name: Elonva, Puregon, Orgalutran, Predalon, Crinone
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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients with an indication for IVF or ICSI
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206803

Locations
Germany
Fertility Center Kiel
Kiel, S-H, Germany, 24103
University Hospital of Schleswig-Holstein, Campus Luebeck
Luebeck, Schleswig-Holstein, Germany, 23538
Prof. Axel Kamischke
Münster, Germany, 48143
Sabine Segerer
Würzburg, Germany, 97080
Norway
Klinikk Hausken
Haugesund, Norway, 5531
Sponsors and Collaborators
University of Schleswig-Holstein
  More Information

Responsible Party: Georg Griesinger, Prof. Dr. med. Georg Griesinger, M.Sc., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01206803     History of Changes
Other Study ID Numbers: GR 3422/3-1 
Study First Received: September 21, 2010
Last Updated: January 4, 2016
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 August 22, 2016