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Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks

NCT01887652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-06-26

No results posted yet for this study

Summary

The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.

Conditions

Interventions

OTHER

conventional ovarian stimulation

a protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation.

OTHER

individualized ovarian stimulation

After defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response.

Sponsors & Collaborators

  • ANDROFERT - Clinica de Andrologia e Reproducao Humana

    lead OTHER

Principal Investigators

  • Rogerio BF Leao, MD · ANDROFERT - Clinica de Andrologia e Reproducao Humana

  • Sandro C Esteves, PhD · ANDROFERT - Clinica de Andrologia e Reproducao Humana

  • Fabiana Y Nakano · ANDROFERT - Clinica de Andrologia e Reproducao Humana

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887652 on ClinicalTrials.gov