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

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887652
• Other study ID #: ANDRO-03-12
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: June 24, 2014
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: ANDROFERT - Clinica de Andrologia e Reproducao Humana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women with in vitro fertilization treatment indication

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• conventional ovarian stimulation
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
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.

Locations

Country	Name	City	State
Brazil	Androfert	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
ANDROFERT - Clinica de Andrologia e Reproducao Humana

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of oocytes retrieved	number of oocyte retrieved classified as: poor response: =4 oocytes normal response: 5 - 19 oocytes excessive response: =20 oocytes	1 day (on the day of oocyte retrieval)	No
Secondary	clinical pregnancy rate	presence of fetal heartbeat on transvaginal ultrasound	4 weeks after embryo transfer	No
Secondary	occurrence of ovarian hyperstimulation syndrome	presence of hyperstimulation syndrome during follow up after oocyte retrieval	4 weeks after embryo transfer	Yes
Secondary	cancellation	cancellation of the cycle because of no ovarian response (no follicles >14 mm during ovarian stimulation)	on the 8th day of ovarian stimulation	No