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Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02046655
Enrollment
80
Registered
2014-01-28
Start date
2011-01-31
Completion date
Unknown
Last updated
2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility

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.

Interventions

DRUGCorifollitropin alfa
DRUGrFSH

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total number of retrieved oocytes36 h after human chorionic gonadotrophin (hCG) administration

Secondary

MeasureTime frame
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)At 6-8 weeks of gestation
Number of embryos transferred2 days following oocyte retrieval

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026