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Completed

NCT Number: NCT01887652

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Androfert

Campinas, São Paulo, 13075-460, Brazil

About this study

A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women with in vitro fertilization treatment indication

Exclusion criteria

  • none

Treatment and study plan

conventional ovarian stimulation

Other

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.

individualized ovarian stimulation

Other

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.

Primary outcomes

  1. number of oocytes retrieved

    Time frame: 1 day (on the day of oocyte retrieval)

    number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 4 weeks after embryo transfer

    presence of fetal heartbeat on transvaginal ultrasound

  2. occurrence of ovarian hyperstimulation syndrome

    Time frame: 4 weeks after embryo transfer

    presence of hyperstimulation syndrome during follow up after oocyte retrieval

  3. cancellation

    Time frame: on the 8th day of ovarian stimulation

    cancellation of the cycle because of no ovarian response (no follicles >14 mm during ovarian stimulation)

Sponsors and collaborators

Lead sponsor

ANDROFERT - Clinica de Andrologia e Reproducao Humana

Other

Registry information

Official study title

Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2013
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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