Prediction of Ovarian Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557687
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : February 26, 2015
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki

Brief Summary:
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 or disease
In Vitro Fertilization

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.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Ovarian Response After Ovarian Stimulation for in Vitro Fertilization
Study Start Date : May 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Primary Outcome Measures :
  1. prediction of poor ovarian response [ Time Frame: at oocyte retrieval ]

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557687

Unit for Human Reproduction
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Study Director: Basil C Tarlatzis Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology

Responsible Party: E.M. Kolibianakis, Professor, Aristotle University Of Thessaloniki Identifier: NCT00557687     History of Changes
Other Study ID Numbers: UHR-5
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by E.M. Kolibianakis, Aristotle University Of Thessaloniki:
ovarian reserve
poor response