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

NCT ID: NCT02237781

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Female Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gonadotropins

Intervention Type: DRUG

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 .

Interventions

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 .

Intervention Type: DRUG

Other Intervention Names

Menopure; Gonal

Eligibility Criteria

Inclusion Criteria

• All infertile women undergoing ovarian stimulation for IVF.

Exclusion Criteria

• Women who can not undergo IVF

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lito Maternity Hospital

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Nikos Vlahos

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikos Vlahos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Athens, 2nd Department of Obstetrics and Gynecology

Central Contacts

Nikos Vlahos, MD

Role: CONTACT

nikosvlahos@med.uoa.gr

30 210 7286000 ext. 256

Olga Triantafyllidou, MD

Role: CONTACT

triantafyllidouolga@yahoo.com

30 2107485591

Other Identifiers

NV24042014

Identifier Type: -

Identifier Source: org_study_id