Double Pick up in Poor Prognosis Women

Fertility Disorders Clinical Trial

— DUOPICK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846544
• Other study ID #: 58335
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: April 2024
• Source: CRG UZ Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Jette

Sponsors (1)

Lead Sponsor	Collaborator
CRG UZ Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MII Oocytes Retrieved Between the Two Arms	number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval	1 month
Secondary	Number of Preovulatory Follicles	number of follicles =11m on the day of final oocyte maturation trigger	1 month
Secondary	Number of Cumulus Oocyte Complexes (COCs) Retrieved	number of COCs retrieved at oocyte retrieval	1 month
Secondary	Number of Oocytes Fertilized	number of fertilized oocytes at day 1 after oocyte retrieval	1 month
Secondary	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
Secondary	Duration of Ovarian Stimulation	number of days of ovarian stimulation	1 month
Secondary	Clinical Pregnancy Rates	clinical pregnancy rate	4 months
Secondary	Live Birth Rates	number of live births	12 months
Secondary	Cumulative Live Birth Rates	defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos	24 months