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

• Sponsor: Pınar Özcan Cenksoy (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01948804
• Collaborator: (none)
• Enrollment: 100
• Arm: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Poor Responders Undergoing IVF	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)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: 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 Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Mar 1, 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. clinical pregnancy rates [6 months]

Secondary Outcome Measures

1. total number of oocytes retrieved [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pınar Özcan Cenksoy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pınar Özcan Cenksoy, Medical Doctor, Yeditepe University Hospital
• ClinicalTrials.gov Identifier: NCT01948804
• Other Study ID Numbers: ytu-123; ytu-123
• First Posted: Sep 24, 2013
• Last Update Posted: Jan 15, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Letrozole; Clomiphene; Cetrorelix; Prolactin Release-Inhibiting Factors

Study Results

No Results Posted as of Jan 15, 2014