NCT02237781

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

September 9, 2014

Last Update Submit

September 10, 2014

Conditions

Female Infertility

Keywords

AMHIVFovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • Level of AMH

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

    6 months

Study Arms (1)

AMH levels

EXPERIMENTAL

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

Interventions

GonadotropinsDRUG

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 .

Also known as: Menopure, Gonal
AMH levels

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All infertile women undergoing ovarian stimulation for IVF.

You may not qualify if:

  • Women who can not undergo IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

Gonadotropinsfollitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Nikos Vlahos, MD

    University of Athens, 2nd Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikos Vlahos, MD

CONTACT

30 210 7286000nikosvlahos@med.uoa.gr

Olga Triantafyllidou, MD

CONTACT

30 2107485591triantafyllidouolga@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

September 11, 2014

Record last verified: 2014-09