Double Pick up in Poor Prognosis Women

CRG UZ Brussel48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fertility Disorders

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

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Brussel

Brussels, Jette, Belgium

Outcomes

Primary Outcomes

Number of MII Oocytes Retrieved Between the Two Arms

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

Time frame: 1 month

Secondary Outcomes

Number of Preovulatory Follicles

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

Time frame: 1 month

Number of Cumulus Oocyte Complexes (COCs) Retrieved

number of COCs retrieved at oocyte retrieval

Time frame: 1 month

Number of Oocytes Fertilized

number of fertilized oocytes at day 1 after oocyte retrieval

Time frame: 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

Time frame: 1 month

Duration of Ovarian Stimulation

number of days of ovarian stimulation

Time frame: 1 month

Clinical Pregnancy Rates

clinical pregnancy rate

Time frame: 4 months

Live Birth Rates

number of live births

Time frame: 12 months

Cumulative Live Birth Rates

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

Data from ClinicalTrials.gov

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