Clinical trial NCT01887652: Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In Vitro Fertilization
ovulation induction
anti-mullerian hormone
Lead sponsor: ANDROFERT - Clinica de Andrologia e Reproducao Humana
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* women with in vitro fertilization treatment indication

Exclusion Criteria:

* none

Primary outcomes:
measure: number of oocytes retrieved
timeFrame: 1 day (on the day of oocyte retrieval)
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
measure: occurrence of ovarian hyperstimulation syndrome
timeFrame: 4 weeks after embryo transfer
measure: cancellation
timeFrame: on the 8th day of ovarian stimulation
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Androfert
state: São Paulo
Study officials:
affiliation: ANDROFERT - Clinica de Andrologia e Reproducao Humana
name: Rogerio BF Leao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ANDROFERT - Clinica de Andrologia e Reproducao Humana
name: Sandro C Esteves, PhD
role: STUDY_DIRECTOR
affiliation: ANDROFERT - Clinica de Andrologia e Reproducao Humana
name: Fabiana Y Nakano
role: STUDY_CHAIR
References: