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Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients

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ClinicalTrials.gov Identifier: NCT01206803
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Georg Griesinger, University Hospital Schleswig-Holstein

Study Description
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Brief 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 gonadotropins).

Condition or disease Intervention/treatment
Infertility, Subfertility Drug: Ovarian stimulation in a GnRH-antagonist protocol

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
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Study Type : Observational
Actual Enrollment : 294 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014
Groups and Cohorts
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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

Outcome Measures
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Primary Outcome Measures :
  1. number of cumulus-oocyte-complexes [ Time Frame: at the time of oocyte retrieval ]
    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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206803


Locations
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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 Hospital Schleswig-Holstein
More Information
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Responsible Party: Georg Griesinger, Prof. Dr. med. Georg Griesinger, M.Sc., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01206803    
Other Study ID Numbers: GR 3422/3-1
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by Georg Griesinger, University Hospital Schleswig-Holstein:
ovarian stimulation
recombinant FSH
GnRH-antagonist
corifollitropin alfa
Additional relevant MeSH terms:
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Infertility
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs