Double Pick up in Poor Prognosis Women (DUOPICK)

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

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 Overview

• Status: Completed
• Conditions: Fertility Disorders
• Intervention / Treatment: Drug: Corifollitoropin alfa (CFA)-double pick up

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Jette
    • Brussels, Jette, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 25-40 years
• Body mass index (BMI) ≤ 35 and ≥ 19
• Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.

Exclusion Criteria:

• Testicular sperm extraction
• History of > 3 three consecutive previous unsuccessful IVF cycles
• BMI >35 or <19
• Use of oral contraceptives <3 months before start of the treatment
• polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
• Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
• Medical/social freezing
• In vitro maturation (IVM)
• History of untreated autoimmune, endocrine or metabolic disorders,
• Ovarian cystectomy or oophorectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: double pick up group	Drug: Corifollitoropin alfa (CFA)-double pick up; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MII Oocytes Retrieved Between the Two Arms	number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Live Birth Rates	defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos	24 months
Number of Preovulatory Follicles	number of follicles ≥11m on the day of final oocyte maturation trigger	1 month
Number of Cumulus Oocyte Complexes (COCs) Retrieved	number of COCs retrieved at oocyte retrieval	1 month
Number of Oocytes Fertilized	number of fertilized oocytes at day 1 after oocyte retrieval	1 month
Total Number of Available Embryos	number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable	1 month
Duration of Ovarian Stimulation	number of days of ovarian stimulation	1 month
Clinical Pregnancy Rates	clinical pregnancy rate	4 months
Live Birth Rates	number of live births	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Follicular Fluid (FF) and ii) Cumulus Cells (CC) Analysis From Each COC	12 months

Collaborators and Investigators

• Sponsor: CRG UZ Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 58335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No