Back to resultsLevels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
Primary Purpose
Female Infertility
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gonadotropins
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility focused on measuring AMH, IVF, ovarian stimulation
Eligibility Criteria
Inclusion Criteria:
- All infertile women undergoing ovarian stimulation for IVF.
Exclusion Criteria:
- Women who can not undergo IVF
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMH levels
Arm Description
Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Levels of AMH will be measured prior and during the ovarian stimulation.
Outcomes
Primary Outcome Measures
Level of AMH
Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.
Secondary Outcome Measures
Full Information
NCT ID
NCT02237781
First Posted
September 9, 2014
Last Updated
September 10, 2014
Sponsor
University of Athens
Collaborators
Lito Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02237781
Brief Title
Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
Official Title
Prospective Randomized Trial on the Level of Anti-Mullerian Hormone (AMH) in Women Undergoing Controlled Ovarian Stimulation for IVFwith Gonadotropins.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
Collaborators
Lito Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF about the effect of ovarian stimulation on the levels of AMH due to the increasing size of follicles and chances of success of the method.
Detailed Description
Patients undergoing IVF will be included in the study. All patients will be counseled regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2) and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated with of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and 5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5. Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue every second day untill the oocyte retrieval. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
AMH, IVF, ovarian stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMH levels
Arm Type
Experimental
Arm Description
Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Levels of AMH will be measured prior and during the ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
Gonadotropins
Other Intervention Name(s)
Menopure, Gonal
Intervention Description
The dose of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH will depend on the levels of E2 and FSH prior to ovarian stimulation .
Primary Outcome Measure Information:
Title
Level of AMH
Description
Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All infertile women undergoing ovarian stimulation for IVF.
Exclusion Criteria:
Women who can not undergo IVF
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikos Vlahos, MD
Phone
30 210 7286000
Ext
256
Email
nikosvlahos@med.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Triantafyllidou, MD
Phone
30 2107485591
Email
triantafyllidouolga@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikos Vlahos, MD
Organizational Affiliation
University of Athens, 2nd Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
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