Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients

Infertility, Subfertility Clinical Trial

Official title:

Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206803
• Other study ID #: GR 3422/3-1
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: January 4, 2016
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2016
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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 gonadotropins).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility, Subfertility

Intervention

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

Locations

Country	Name	City	State
Germany	Fertility Center Kiel	Kiel	S-H
Germany	University Hospital of Schleswig-Holstein, Campus Luebeck	Luebeck	Schleswig-Holstein
Germany	Prof. Axel Kamischke	Münster
Germany	Sabine Segerer	Würzburg
Norway	Klinikk Hausken	Haugesund

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cumulus-oocyte-complexes	the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation	at the time of oocyte retrieval	No