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Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins

Sponsor
University of Athens (Other)
Overall Status
Unknown status
CT.gov ID
NCT02237781
Collaborator
Lito Maternity Hospital (Other)
50
Enrollment
1
Arm
14
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Trial on the Level of Anti-Mullerian Hormone (AMH) in Women Undergoing Controlled Ovarian Stimulation for IVFwith Gonadotropins.
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMH levels

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.

Drug: Gonadotropins
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 .
Other Names:
  • Menopure
  • Gonal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Level of AMH [6 months]

      Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All infertile women undergoing ovarian stimulation for IVF.
    Exclusion Criteria:
    • Women who can not undergo IVF

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Athens
    • Lito Maternity Hospital

    Investigators

    • Principal Investigator: Nikos Vlahos, MD, University of Athens, 2nd Department of Obstetrics and Gynecology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nikos Vlahos, Associate Professor of Obstetrics and Gynecology, University of Athens
    ClinicalTrials.gov Identifier:
    NCT02237781
    Other Study ID Numbers:
    • NV24042014
    First Posted:
    Sep 11, 2014
    Last Update Posted:
    Sep 11, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Nikos Vlahos, Associate Professor of Obstetrics and Gynecology, University of Athens
    AMH
    IVF
    ovarian stimulation
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Sep 11, 2014