Double Pick up in Poor Prognosis Women

Phase 4

Completed

• Conditions: Fertility Disorders
• Interventions: Drug: Corifollitoropin alfa (CFA)-double pick up

• Registration Number: NCT03846544
• Lead Sponsor: CRG UZ Brussel

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-19
• Study Start: 2019-10-01
• Primary Completion: 2021-09-15
• Study Completion: 2022-10-01
• Results First Submitted: 2023-10-23
• Results First Submitted QC: 2023-10-23
• Status Verified: 2024-04
• Results First Posted: 2024-04-15
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double pick up group	Corifollitoropin alfa (CFA)-double pick up	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Jette, Belgium