CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Corifollitoropin alfa (CFA)-double pick updrug
Likely dose
225 IU recombinant FSH (rFSH) continued after first oocyte retrievalAI-extracted
Key inclusion· 3
  • Age 25-40 years
  • BMI between 19 and 35 kg/m²
  • Low ovarian reserve defined as AMH ≤1.5 ng/mL, AFC ≤6 follicles, or ≤5 oocytes in prior cycle
Key exclusion· 8
  • History of >3 consecutive previous unsuccessful IVF cycles
  • PCOS diagnosis by Rotterdam criteria
  • BMI <19 or >35 kg/m²
  • Oral contraceptives used within 3 months of treatment start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03846544
NCT03846544Phase 4Completed

Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study

CRG UZ Brussel·interventional·Posted Feb 19, 2019·Updated May 21, 2024

In Brief

A Phase 4 clinical trial evaluating Corifollitoropin alfa (CFA)-double pick up for Fertility Disorders. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 19, 2019
Enrollment StartOct 1, 2019
Primary CompletionSep 15, 2021
Study CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.4 years ago

Interventions

Corifollitoropin alfa (CFA)-double pick updrug

In the study group, 225 IU of recombinant FSH (rFSH) will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with human chorionic gonadotropin (hCG) 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR