Gene-polymorphisms Relating to Human Subfertility

NCT01385618 | Completed

• 1 other identifier: PRP-ERP2010
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Estradiol Receptor Polymorphism; Progesterone Receptor Polymorphism; IVF; Subfertility

Outcome Measures

Primary Outcomes (1)

• genetic testing for two estrogene receptor genes, correlating to numbers of oocytes retrieved at oocyte punction after hormonal stimulation

  30.06.2013

Study Arms (3)

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 Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients at reproductive age seeking IVF treatment

You may qualify if:

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

You may not qualify if:

• other fertility treatments like IUI or timed intercourse

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Andreas Neuer

  Infertility Treatment Center Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

DE (1)