The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.

The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.

The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.

Study Overview

• Status: Unknown
• Conditions: Poor Responders Undergoing IVF
• Intervention / Treatment: Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG); Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono); Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma); Drug: GnRH antagonist protocol (Cetrotide, Serono)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Criteria for definition of poor responders included at least one of the following

1. Anti müllerian hormone <1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).
2. Primary infertile patients
3. BMI≤30 kg/m2 were included this study.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVF patients; patients that has applied to Yeditepe University Hospital assisted reproduction center	Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG); Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono); Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma); Drug: GnRH antagonist protocol (Cetrotide, Serono)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical pregnancy rates	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
total number of oocytes retrieved	6 months

Collaborators and Investigators

• Sponsor: Pınar Özcan Cenksoy

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Cetrorelix; Clomiphene; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: ytu-123 (Other Identifier: YeditepeUH)