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Completed

NCT Number: NCT03846544

Double Pick up in Poor Prognosis Women

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).

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Key information

Conditions

Fertility Disorders

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UZ Brussel

Brussels, Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Corifollitoropin alfa (CFA)-double pick up

Drug

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

Primary outcomes

  1. Number of MII Oocytes Retrieved Between the Two Arms

    Time frame: 1 month

    number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval

Secondary outcomes

  1. Number of Preovulatory Follicles

    Time frame: 1 month

    number of follicles ≥11m on the day of final oocyte maturation trigger

  2. Number of Cumulus Oocyte Complexes (COCs) Retrieved

    Time frame: 1 month

    number of COCs retrieved at oocyte retrieval

  3. Number of Oocytes Fertilized

    Time frame: 1 month

    number of fertilized oocytes at day 1 after oocyte retrieval

  4. Total Number of Available Embryos

    Time frame: 1 month

    number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable

  5. Duration of Ovarian Stimulation

    Time frame: 1 month

    number of days of ovarian stimulation

  6. Clinical Pregnancy Rates

    Time frame: 4 months

    clinical pregnancy rate

  7. Live Birth Rates

    Time frame: 12 months

    number of live births

  8. Cumulative Live Birth Rates

    Time frame: 24 months

    defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos

Sponsors and collaborators

Lead sponsor

CRG UZ Brussel

Other

Registry information

Official study title

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

Acronym: DUOPICK

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 19, 2019
Registry last updated
May 21, 2024

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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