Double Pick up in Poor Prognosis Women

NCT03846544 | Completed Phase 4 Results

• 1 other identifier: 58335
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• Number of MII Oocytes Retrieved Between the Two Arms

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

  1 month

Secondary Outcomes (8)

• Number of Preovulatory Follicles

  1 month

• Number of Cumulus Oocyte Complexes (COCs) Retrieved

  1 month

• Number of Oocytes Fertilized

  1 month

• Total Number of Available Embryos

  1 month

• Duration of Ovarian Stimulation

  1 month

Study Arms (2)

control group

NO INTERVENTION

double pick up group

EXPERIMENTAL

Drug: Corifollitoropin alfa (CFA)-double pick up

Interventions

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

double pick up group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CRG UZ Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Jette, 1090, Belgium

Location

Related Publications (1)

• Boudry L, Mateizel I, Wouters K, Papaleo E, Mackens S, De Vos M, Racca A, Adriaenssens T, Tournaye H, Blockeel C. Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled trial. Hum Reprod. 2024 Mar 1;39(3):538-547. doi: 10.1093/humrep/dead276.

  PMID: 38199789 DERIVED

Results Point of Contact

• Title: Dr Liese Boudry
• Organization: Brussels IVF

liese.boudry@uzbrussel.be

024779857

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: October 1, 2019
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2022
• Last Updated: May 21, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)