NCT02099916

Brief Summary

Poor responders to ovarian stimulation represents one of the most frustrating problems in reproductive medicine. The investigators hypothesize that ovarian response of those patients could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to stimulation.

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

March 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
6 months 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 10, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

March 26, 2014

Last Update Submit

September 9, 2014

Conditions

Efficacy of DHEAPregnancy RateDiminished Ovarian ReserveChanges in AMH

Keywords

DHEA, pregnancy, ovarian reserve, AMH

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy

    At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.

    At 12 weeks after DHEA administration and at 18 months

Secondary Outcomes (1)

  • changes in ovarian reserve indexes

    6 months

Study Arms (2)

gonadotropins plus DHEA

ACTIVE COMPARATOR

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Prior to the stimulation will be treated with DHEA 25 mg PO tid for 12 weeks.

Drug: gonadotropins plus DHEADrug: Gonadotropins

Gonadotropins

ACTIVE COMPARATOR

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists.

Drug: gonadotropins plus DHEADrug: Gonadotropins

Interventions

gonadotropins plus DHEADRUG

Women in the DHEA group will received 25 mg of DHEA three times a day for at least 12 weeks.

Also known as: DHEA
Gonadotropinsgonadotropins plus DHEA
GonadotropinsDRUG

All patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU 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.

Also known as: Menopur 75IU, Gonal
Gonadotropinsgonadotropins plus DHEA

Eligibility Criteria

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

You may qualify if:

  • Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.

You may not qualify if:

  • All other women that do not fulfill the above mentioned criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

GonadotropinsDehydroepiandrosteroneMenotropins

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesTestosterone CongenersGonadal Steroid HormonesGonadal HormonesGonadotropins, PituitaryPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Nikos Vlahos, AssProfessor

    University of Athens, 2nd Department of Obstetrics and Gynecology

    STUDY CHAIR

Central Study Contacts

Nikos vlahos, MD

CONTACT

30 210 7286000nikosvlahos@med.uoa.gr

Olga Triantafillidou, MD

CONTACT

30 2107485591triantafyllidouolga@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 31, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

September 10, 2014

Record last verified: 2014-09