CClinicalTrials.gg
CompletedNCT01385618Updated Mar 25, 2015

Gene-polymorphisms Relating to Human Subfertility

An observational study in Estradiol Receptor Polymorphism, Progesterone Receptor Polymorphism and IVF, sponsored by Infertility Treatment Center Dortmund. Completed at 1 site in Germany. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Infertility Treatment Center Dortmund · Observational

Study type
Observational
Model
Case-control
Enrollment
150
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Estradiol Receptor Polymorphism
  • Progesterone Receptor Polymorphism
  • IVF
  • Subfertility

Browse trials for

03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Infertility Treatment Center Dortmund is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Female patients at reproductive age seeking IVF treatment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • other fertility treatments like IUI or timed intercourse
05

Study design

Observational model
Case-control
Enrollment
150 participants (actual)
Biospecimen retention
Samples with dna

Groups and 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

06

What researchers measure

Primary outcomes

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

    Time frame: 30.06.2013

07

Study locations

1 site
  • Infertility treatment center Dortmund
    Dortmund, NRW 44135, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01385618
Lead sponsor
Infertility Treatment Center Dortmund
Collaborators
Weill Medical College of Cornell University
Responsible party
Prof. Dr. Stefan Dieterle (Prof. Dr., Infertility Treatment Center Dortmund) — Principal investigator
First posted
Jun 30, 2011
Start date
Oct 2010
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 25, 2015

Study contacts

Andreas Neuer
principal investigator · Infertility Treatment Center Dortmund

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion