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Dual egg retrieaval for poor prognosis women

Double trigger and ovum retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis women undergoing IVF/ICSI: A pilot study - DUOPICK

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2019-000971-17-BE
Enrollment
46
Registered
2019-05-14
Start date
2019-07-17
Completion date
Unknown
Last updated
2024-03-12

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

Conditions

infertility

Interventions

Trade Name: Elonva Product Name: Elonva Pharmaceutical Form: Solution for injection INN or Proposed INN: CORIFOLLITROPIN ALFA CAS Number: 195962-23-3 Current Sponsor code: 58335-Elonva Concentration u

Sponsors

UZ Brussel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age 25-40 years - BMI = 35 and = 19 -Antimüllerian hormone (AMH) level of =1.5 ng/mL or antral follicular count of =6 follicles or =5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation. - =9 follicles >11 mm on the day of first trigger Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: history of more than three consecutive previous unsuccessful IVF/ICSI cycles, BMI >35 or 3 months before start of the treatment, testicular sperm extraction; history of untreated autoimmune, endocrine or metabolic disorders, ovarian cystectomy or oophorectomy.

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of this pilot study is to compare the efficacy of double trigger with GnRH agonist vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing IVF/ICSI. ;Secondary Objective: Not applicable;Primary end point(s): Number of metaphase II (MIIs) oocytes ;Timepoint(s) of evaluation of this end point: 1 month

Secondary

MeasureTime frame
Secondary end point(s): Secondary outcome measures will include: number of preovulatory follicles, number of cumulus oocyte complexes (COCs) retrieved, number of oocytes fertilized, total number of available embryos, duration of stimulation, total dose of gonadotropins administered, clinical pregnancy and live birth rates and cumulative live birth rates (defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos). In both groups, measurement (mean diameter) of all aspirated follicles will be performed on the day of the first and second OR (for group B). ;Timepoint(s) of evaluation of this end point: 2 years

Countries

Belgium

Contacts

Public ContactPanagiotis Drakopoulos

UZ Brussel

00320468180349

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026