Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

May 8, 2015 updated by: Dr.ssa Raffaella Depalo, U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Predictors of Ovarian Response in Women Undergoing Ovarian Stimulation for IVF

Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of 347 cycles performed with three different protocols.

Study Overview

Status

Completed

Conditions

Detailed Description

347 IVF cycles (236 patients) analyzed for a retrospective study to evaluate the correlation between the biomarkers of ovarian reserve (antral follicles count, antimullerian hormone, basal follicle stimulating hormone) and number of oocytes and mature oocytes (MII) retrieved during the pick up. For the stimulation were used three different protocols: long luteal, antagonist with daily administration of gonadotropins and antagonist with depot administration of gonadotropins.

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with primary or secondary infertility who underwent ovarian stimulation for in vitro fertilization in our centre.

Description

Inclusion Criteria:

  • women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization.

Exclusion Criteria:

  • women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Long luteal protocol
Subcutaneous administration of GnRH agonist (Triptorelina pamoato 0.1 mg/ml) in the medium-luteal phase (21th day) of the cycle before the stimulation. The next menstruation, in the presence of estradiol level (E2)<30pg/ml and in the absence of follicular cysts, the gonadotropin stimulation was begun. In the presence of at least three follicles of diameter ≥18mm was induced final oocyte maturation by administration of human chorionic gonadotropin (hCG).
Daily antagonist protocol
GnRH antagonist (cetrorelix acetate 0.25 mg) was administered subcutaneously with a fixed protocol from the day +6 of stimulation or with a flexible protocol from the day in which at least one follicle reached a diameter of 14mm. In both protocols GnRH antagonist was administered until the day of the assumption of hCG. Recombinant Follicle Stimulating Hormone (rFSH) was administered from the 3rd day of menstruation at a dose of 150-300 IU/die according to the characteristics of women. The hCG was administered when at least three follicles had reached 18 mm in diameter and estradiol levels were higher than 150 pg/mL/dominant follicle.
Depot antagonist protocol

GnRH antagonist (Cetrorelix acetate 0.25 mg) was administered subcutaneously with a fixed or flexible protocol until the day of the assumption of hCG. Corifollitropila alfa was used at dose of 100μg (in women with weight ≤60 kg and age ≤36 years) or 150μg (in women with weight> 60 kg of any age or weight ≥50 kg and age greater than 36 years). Corifollitropina alfa was administered subcutaneously in the day +3 and in the day +5 or +6 was supplemented with rFSH at doses 112-300 IU/day.

The hCG was administered when at least three follicles had reached 18 mm in diameter and estradiol levels were higher than 150 pg/mL/dominant follicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of total and mature (MII) oocytes
Time Frame: 10 months
the number of total and mature (MII) oocytes retrieved during the pick up.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of stimulation
Time Frame: 10 months
the number of days since the administration of rFSH o corifollitropina alfa until the administration of hCG
10 months
ovarian sensitivity index or OSI
Time Frame: 10 months
OSI was calculated dividing the total administered FSH dose by the number of retrieved oocytes
10 months
pregnancy rate
Time Frame: 10 months
the number of positive pregnancy tests with the evidence of an embyo with cardiac activity.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Investigators

  • Study Director: Raffaella Depalo, MD, U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uospmacg2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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