NCT02293668

Brief Summary

There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
9 months 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

9 months

First QC Date

November 14, 2014

Last Update Submit

January 7, 2016

Conditions

Infertility

Keywords

poor responders

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    8 weeks

Secondary Outcomes (3)

  • Number of oocytes retrieved

    4 weeks

  • Number of transferable embryos

    4 weeks

  • Biochemical pregnancy rate

    6 weeks

Study Arms (3)

Combined 450

ACTIVE COMPARATOR

Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: FSH 225IU and hMG 225IU

Combined 300

ACTIVE COMPARATOR

Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Drug: FSH 150IU and hMG 150IU

Letrozole and hMG

ACTIVE COMPARATOR

Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/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: Letrozole 5mg and hMG 150IU

Interventions

FSH 225IU and hMG 225IUDRUG
Combined 450
FSH 150IU and hMG 150IUDRUG
Combined 300
Letrozole 5mg and hMG 150IUDRUG
Letrozole and 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)

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

Conditions

Infertility

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

November 14, 2014

First Posted

November 18, 2014

Study Start

November 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)