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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02237781
Other study ID # NV24042014
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received September 9, 2014
Last updated September 10, 2014
Start date October 2014
Est. completion date December 2015

Study information

Verified date September 2014
Source University of Athens
Contact Nikos Vlahos, MD
Phone 30 210 7286000
Email nikosvlahos@med.uoa.gr
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- All infertile women undergoing ovarian stimulation for IVF.

Exclusion Criteria:

- Women who can not undergo IVF

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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 .

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Athens Lito Maternity Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Level of AMH Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation. 6 months No
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