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Clinical Trials/NCT03846544
NCT03846544CompletedPhase 4

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

CRG UZ Brussel1 site in 1 country48 target enrollmentStarted: October 1, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
Number of MII Oocytes Retrieved Between the Two Arms
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
25 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

double pick up group

Experimental

Intervention: Corifollitoropin alfa (CFA)-double pick up (Drug)

Outcomes

Primary Outcomes

Number of MII Oocytes Retrieved Between the Two Arms

Time Frame: 1 month

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

Secondary Outcomes

  • 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)
  • Live Birth Rates(12 months)
  • Duration of Ovarian Stimulation(1 month)
  • Clinical Pregnancy Rates(4 months)
  • Cumulative Live Birth Rates(24 months)

Investigators

Sponsor
CRG UZ Brussel
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Panagiotis Drakopoulos

Prof. Dr.

CRG UZ Brussel

Study Sites (1)

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