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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
conventional ovarian stimulation
individualized ovarian stimulation
Sponsored by
ANDROFERT - Clinica de Andrologia e Reproducao Humana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In Vitro Fertilization, ovulation induction, anti-mullerian hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with in vitro fertilization treatment indication

Exclusion Criteria:

  • none

Sites / Locations

  • Androfert

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional ovarian stimulation

individualized ovarian stimulation

Arm Description

women whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment

women whose protocol of ovarian stimulation was based on anti-mullerian hormone

Outcomes

Primary Outcome Measures

number of oocytes retrieved
number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes

Secondary Outcome Measures

clinical pregnancy rate
presence of fetal heartbeat on transvaginal ultrasound
occurrence of ovarian hyperstimulation syndrome
presence of hyperstimulation syndrome during follow up after oocyte retrieval
cancellation
cancellation of the cycle because of no ovarian response (no follicles >14 mm during ovarian stimulation)

Full Information

First Posted
June 24, 2013
Last Updated
June 24, 2014
Sponsor
ANDROFERT - Clinica de Andrologia e Reproducao Humana
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1. Study Identification

Unique Protocol Identification Number
NCT01887652
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANDROFERT - Clinica de Andrologia e Reproducao Humana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro Fertilization, ovulation induction, anti-mullerian hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional ovarian stimulation
Arm Type
Active Comparator
Arm Description
women whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment
Arm Title
individualized ovarian stimulation
Arm Type
Active Comparator
Arm Description
women whose protocol of ovarian stimulation was based on anti-mullerian hormone
Intervention Type
Other
Intervention Name(s)
conventional ovarian stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
individualized ovarian stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of oocytes retrieved
Description
number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes
Time Frame
1 day (on the day of oocyte retrieval)
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
presence of fetal heartbeat on transvaginal ultrasound
Time Frame
4 weeks after embryo transfer
Title
occurrence of ovarian hyperstimulation syndrome
Description
presence of hyperstimulation syndrome during follow up after oocyte retrieval
Time Frame
4 weeks after embryo transfer
Title
cancellation
Description
cancellation of the cycle because of no ovarian response (no follicles >14 mm during ovarian stimulation)
Time Frame
on the 8th day of ovarian stimulation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with in vitro fertilization treatment indication Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio BF Leao, MD
Organizational Affiliation
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandro C Esteves, PhD
Organizational Affiliation
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fabiana Y Nakano
Organizational Affiliation
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Official's Role
Study Chair
Facility Information:
Facility Name
Androfert
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13075-460
Country
Brazil

12. IPD Sharing Statement

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

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