Gene-polymorphisms Relating to Human Subfertility

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Infertility Treatment Center Dortmund
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Prof. Dr. Stefan Dieterle, Infertility Treatment Center Dortmund
ClinicalTrials.gov Identifier:
NCT01385618
First received: June 29, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role in maturation and fertilization of oocytes. Furthermore it is involved in development of secondary female sexual organs, fertility and maintenance of pregnancy.

Estradiol influences these processes by binding to estradiol receptors (ER). They are ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several polymorphisms and mutations are known which can be linked to breast cancer, spontaneous abortions, osteoporosis and the point in time of menarche. Furthermore some studies have shown a relationship between certain polymorphisms and the risk of infertility associated gynecological malfunctions and the result of IVF treatments.

Progesterone is a hormone which plays a crucial role in initiation and maintenance of pregnancy. It induces the transformation of the endometrium, which facilitates the implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by binding to its receptor. The gene for this receptor is polymorph within the population, whereas some variants seem to account for implantation failure of embryos.

In the investigators study the investigators will analyse the role of ERP and PRP polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor gene a single nucleotide exchange at position +331 (G->A) plays a role.

The parameters correlated with are concentrations of estradiol, progesterone and FSH, number of follicles, number of fertilized oocytes and pregnancy rate.

The investigators hope to optimize established treatment protocols and to improve the chances of success of IVF treatments depending on the genotype of the patient.


Condition
Estradiol Receptor Polymorphism
Progesterone Receptor Polymorphism
IVF
Subfertility

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Analysis of Gene-polymorphisms Relating to Human Subfertility: Estradiol-receptor-polymorphism and Progesterone-receptor-polymorphism

Resource links provided by NLM:


Further study details as provided by Infertility Treatment Center Dortmund:

Primary Outcome Measures:
  • genetic testing for two estrogene receptor genes, correlating to numbers of oocytes retrieved at oocyte punction after hormonal stimulation [ Time Frame: 30.06.2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

buccal swabs


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
high responder
females with >15 follicles or E2>3000 after treatment with gonadotropins
low responder
patients with <3 follicles or no response to treatment with gonadotropins
control
females with an indication for treatment because of male subfertility

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female patients at reproductive age seeking IVF treatment

Criteria

Inclusion Criteria:

  • IVF/ ICSI treatment with hormonal stimulation
  • reproductive age
  • high response OR low response OR male subfertility

Exclusion Criteria:

  • other fertility treatments like IUI or timed intercourse
  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: NCT01385618

Locations
Germany
Infertility treatment center Dortmund Recruiting
Dortmund, NRW, Germany, 44135
Contact: Stefan Dieterle, Prof    00492315575450      
Principal Investigator: Andreas Neuer, Dr. med         
Sponsors and Collaborators
Infertility Treatment Center Dortmund
Weill Medical College of Cornell University
Investigators
Principal Investigator: Andreas Neuer Infertility Treatment Center Dortmund
  More Information

No publications provided

Responsible Party: Prof. Dr. Stefan Dieterle, Prof. Dr., Infertility Treatment Center Dortmund
ClinicalTrials.gov Identifier: NCT01385618     History of Changes
Other Study ID Numbers: PRP-ERP2010
Study First Received: June 29, 2011
Last Updated: April 5, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 29, 2014