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

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)

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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