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Completed

NCT Number: NCT02046655

Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corifollitropin alfa

Drug

Other names: Elonva

rFSH

Drug

Other names: Puregon

Primary outcomes

  1. Total number of retrieved oocytes

    Time frame: 36 h after human chorionic gonadotrophin (hCG) administration

Secondary outcomes

  1. 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

  2. Number of embryos transferred

    Time frame: 2 days following oocyte retrieval

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol

Important dates

Study start
2011
Primary completion
2014
First posted
Jan 28, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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