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Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Primary Purpose

Subfertility

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Corifollitropin alfa
rFSH
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Proven poor responders of couples with an indication for COS
  2. ≥ 18 and < 45 years of age
  3. BMI ≥ 18 and ≤ 32 kg/m2
  4. Regular spontaneous menstrual cycle (24-35 days)
  5. Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)

Exclusion Criteria:

  1. PGD or PGS
  2. TESE

Sites / Locations

  • Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Corifollitropin alfa group

rec FSH group

Arm Description

On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm. A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary. Triggering of final oocyte maturation will be performed using 250 μg of rechCG.

On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm. Triggering of final oocyte maturation will be performed using 250 μg of rechCG.

Outcomes

Primary Outcome Measures

Total number of retrieved oocytes

Secondary Outcome Measures

Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Number of embryos transferred

Full Information

First Posted
December 18, 2013
Last Updated
May 13, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT02046655
Brief Title
Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI
Official Title
Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

5. Study Description

Brief Summary
Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success. The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corifollitropin alfa group
Arm Type
Experimental
Arm Description
On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm. A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary. Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
Arm Title
rec FSH group
Arm Type
Active Comparator
Arm Description
On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm. Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
Intervention Type
Drug
Intervention Name(s)
Corifollitropin alfa
Other Intervention Name(s)
Elonva
Intervention Type
Drug
Intervention Name(s)
rFSH
Other Intervention Name(s)
Puregon
Primary Outcome Measure Information:
Title
Total number of retrieved oocytes
Time Frame
36 h after human chorionic gonadotrophin (hCG) administration
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Time Frame
At 6-8 weeks of gestation
Title
Number of embryos transferred
Time Frame
2 days following oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proven poor responders of couples with an indication for COS ≥ 18 and < 45 years of age BMI ≥ 18 and ≤ 32 kg/m2 Regular spontaneous menstrual cycle (24-35 days) Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed) Exclusion Criteria: PGD or PGS TESE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efstratios M Kolibianakis, MD, MSc, PhD
Organizational Affiliation
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
25492411
Citation
Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.
Results Reference
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Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

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