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

A

ANDROFERT - Clinica de Andrologia e Reproducao Humana

Status

Completed

Conditions

Infertility

Treatments

Other: conventional ovarian stimulation
Other: individualized ovarian stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01887652
ANDRO-03-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment

250 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

women with in vitro fertilization treatment indication

Exclusion criteria

none

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

conventional ovarian stimulation
Active Comparator group
Description:
women whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment
Treatment:
Other: conventional ovarian stimulation
individualized ovarian stimulation
Active Comparator group
Description:
women whose protocol of ovarian stimulation was based on anti-mullerian hormone
Treatment:
Other: individualized ovarian stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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