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

Not Applicable

Completed

• Conditions: Infertility

• Registration Number: NCT01887652
• Lead Sponsor: ANDROFERT - Clinica de Andrologia e Reproducao Humana

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-27
• Study Completion: 2013-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• women with in vitro fertilization treatment indication

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of oocytes retrieved	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 Outcome Measures

Name	Time	Method
clinical pregnancy rate	4 weeks after embryo transfer	presence of fetal heartbeat on transvaginal ultrasound
occurrence of ovarian hyperstimulation syndrome	4 weeks after embryo transfer	presence of hyperstimulation syndrome during follow up after oocyte retrieval
cancellation	on the 8th day of ovarian stimulation	cancellation of the cycle because of no ovarian response (no follicles \>14 mm during ovarian stimulation)

Trial Locations

Locations (1)

Androfert; 🇧🇷 Campinas, São Paulo, Brazil