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Prediction of Ovarian Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00557687
First received: November 13, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study is to evaluate if there is an association between the endocrine and ultrasonographic markers of ovarian reserve and the IVF outcome and to determine which markers contribute to the prediction of poor response in IVF.


Condition
In Vitro Fertilization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Ovarian Response After Ovarian Stimulation for in Vitro Fertilization

Further study details as provided by Aristotle University Of Thessaloniki:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 100
Study Start Date: May 2005
Estimated Study Completion Date: June 2008
Detailed Description:

One of the most frustrating problem in IVF today is that of poor ovarian response. There is an amount of woman undergoing infertility treatment, who respond poorly to the usual gonatotrophin stimulation protocol applied. The ovarian response, which is the number of antral follicles and oocytes which are developed in the ovary after stimulation, is correlated directly with the ovarian reserve. As ovarian reserve is defined the existent quantitative and qualitative supply of follicles which are found in the ovaries and potentially can be developed in dominant and therefore it is closely associated with reproductive potential.

There is a plethora of criteria used to characterize the poor response. The number of developed follicles or the number of oocytes retrieved after a standard dose ovarian stimulation protocol, are two of the most substantial criteria for the definition of poor ovarian reserve. Satisfying response after ovulation induction is considered the retrieval of 5-14 oocytes per patient, whereas poor response is considered the retrieval of 4 or less oocytes. Using the standard doses, however, a number of patients will exhibit inappropriate ovarian responses. Exaggerated response leads to increased risk of ovarian hyperstimulation syndrome, while on the other hand, inadequate ovarian response is associated with increased number of IVF cancellations.

During the past two decades, a substantial amount of research has been carried out in order to improve our knowledge on ovarian response predictors. Age has often guided infertility treatment choices, since a woman's chronological age is the single most important factor in predicting a couple's reproductive potential, as it is generally acknowledged that reproductive ageing is related to both quantitative and qualitative reduction of the primordial follicle pool. However, age alone is of limited value and so it cannot predict the response to infertility treatment.

A number of ovarian reserve tests have been designed in order to determine ovarian reserve and have been evaluated for their ability to predict the outcome of IVF. Many of these tests have become part of the routine diagnostic procedure for infertile patients who undergo assisted reproductive techniques. These ovarian reserve tests include the measurement of specific endocrine markers in combination with the study of some ultra-sonographic parameters.

Basal FSH was the first widely used endocrine marker of ovarian reserve that had better potential than age for predicting decreased ovarian function and today it is established that patients with elevated basal FSH levels have lowered success rates after IVF. At present, several other markers of ovarian reserve are advocated, such as basal estradiol levels, basal LH levels, early follicular phase serum inhibin B concentration and anti-mullerian hormone concentration.

Moreover, several ovarian ultrasonographic parameters are studied as markers for ovarian resposiveness. The antral follicle count, the ovarian volume and the ovarian stromal blood flow appeared to be indicative of poor response in assisted reproduction.

The purpose of this prospective study is to evaluate if there is an association between the endocrine and ultrasonographic markers of ovarian reserve and the IVF outcome and to determine which markers contribute to the prediction of poor response in IVF.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing ovarian stimulation with gonadotropins and GnRH antagonists for IVF

Criteria

Inclusion Criteria:

  • Age < 39 years
  • Presence of both ovaries
  • FSH levels < 12,5 IU/l
  • Duration of mensrual cycle >21 days and <35days
  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: NCT00557687

Contacts
Contact: Efstratios Kolibianakis 0030 6937 097 078 stratis.kolibianakis@gmail.com

Locations
Greece
Unit for Human Reproduction Recruiting
Thessaloniki, Greece
Contact: Efstratios Kolibianakis    0030 2310 669374    stratis.kolibianakis@gmail.com   
Sub-Investigator: Maria Ganidou         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Director: Basil C Tarlatzis Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00557687     History of Changes
Other Study ID Numbers: UHR-5
Study First Received: November 13, 2007
Last Updated: November 13, 2007
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Aristotle University Of Thessaloniki:
IVF
ovarian reserve
poor response

ClinicalTrials.gov processed this record on November 25, 2014