NCT02158689

Brief Summary

The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

May 27, 2014

Last Update Submit

January 7, 2016

Conditions

Poor Responders

Keywords

Poor respondersletrozolehuman menopausal gonadotropin

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    The primary outcome measure will be the ongoing pregnancy rate (\>12 weeks' gestation) per started cycle.

    up to 2 weeks

Secondary Outcomes (5)

  • Cancellation Rate

    up to one month

  • Number of oocytes retrieved

    up to one month

  • Number of transferable embryos

    up to one month

  • Implantation rate

    up to 2 weeks

  • Clinical pregnancy rate

    up to 2 weeks

Study Arms (2)

human menopausal gonadotropin (hMG)

ACTIVE COMPARATOR

hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: human menopausal gonadotropin (hMG)

Letrozole

ACTIVE COMPARATOR

Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: Letrozole

Interventions

LetrozoleDRUG
Also known as: Femara
Letrozole
human menopausal gonadotropin (hMG)DRUG
human menopausal gonadotropin (hMG)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
  • Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
  • advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
  • a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
  • an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

    PMID: 21505041BACKGROUND

MeSH Terms

Interventions

LetrozoleMenotropins

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Harika Yumru, M.D.

    Istanbul University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Hasan F Buyru, M.D. Prof.

    Istanbul University School of Medicine

    STUDY CHAIR

  • Ercan Bastu, M.D.

    Istanbul University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

TU(1)