Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prediction of Ovarian Response

This study has been completed.
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki Identifier:
First received: November 13, 2007
Last updated: February 25, 2015
Last verified: February 2015

November 13, 2007
February 25, 2015
May 2005
September 2010   (final data collection date for primary outcome measure)
prediction of poor ovarian response [ Time Frame: at oocyte retrieval ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00557687 on Archive Site
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Prediction of Ovarian Response
Prediction of Ovarian Response After Ovarian Stimulation for in Vitro Fertilization

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.

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.

Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA


Non-Probability Sample

Women undergoing ovarian stimulation with gonadotropins and GnRH antagonists for IVF

In Vitro Fertilization
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age < 39 years
  • Presence of both ovaries
  • FSH levels < 12,5 IU/l
  • Duration of mensrual cycle >21 days and <35days
18 Years to 39 Years
Contact information is only displayed when the study is recruiting subjects
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E.M. Kolibianakis, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
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Study Director: Basil C Tarlatzis Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology
Aristotle University Of Thessaloniki
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP