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: October 2023
• 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 IVF/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
• 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.

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
• 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:
• CFA-double pick up
In the study group, 225 IU of 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 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
Other	Follicular Fluid (FF) and ii) Cumulus Cells (CC) Analysis From Each COC		12 months
Primary	Number of Oocytes Retrieved (Metaphase II Oocytes) Between the Two Arms	number	1 month
Secondary	Number of Preovulatory Follicles		1 month
Secondary	Number of Cumulus Oocyte Complexes (COCs) Retrieved		1 month
Secondary	Number of Oocytes Fertilized		1 month
Secondary	Total Number of Available Embryos		1 month
Secondary	Duration of Ovarian Stimulation		1 month
Secondary	Total Dose of Gonadotropins Administered		1 month
Secondary	Clinical Pregnancy Rates		4 months
Secondary	Live Birth Rates		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