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CompletedNCT01980563Updated Nov 11, 2013

Optimizing Ovarian Stimulation for IVF and ICSI

An interventional study of ultrasound and combined monitoring in Efficiency in Terms of Mature Oocyte Yield, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-11-11.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
416
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) can be simplified by reducing the procedure to measuring follicles by ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to simple monitoring by ultrasound while maintaining results (numbers of mature oocytes, percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling for measuring hormone levels is still the state of the art in many clinics. A large review (Cochrane review) stated that "although there was no clear evidence for a better outcome, combined cycle monitoring was still recommended until it could be proven that ovarian hyperstimulation can be avoided without hormonal monitoring". Investigators therefore perform a study that compares the results between 2 groups: those with ultrasound monitoring and those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend on subtle differences in the number of large follicles measured by ultrasound, but also on hormonal levels in the blood of the patient. Therefore the investigators planned a randomized study in the group of patients with combined monitoring. The investigators examined if delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on the number of mature oocytes and pregnancy rates and what the effect of rising progesterone levels might be. The investigators hypothesis was that combined monitoring could lead to better results since recent studies have thought that rising progesterone levels, if found, have a negative impact on pregnancy rates. On the other hand the investigators expect to find that waiting for larger follicles in cases with normal progesterone levels lead to a better oocyte yield.

02

Conditions studied

  • Efficiency in Terms of Mature Oocyte Yield
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • absence of ovarian cysts
  • both ovaries present

Exclusion criteria

exclusion criteria:

  • ovarian cysts
  • not both ovaries present
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
416 participants (actual)

Study arms

  • Active comparator
    ultrasound

    Procedure: ultrasound · Procedure: combined monitoring

  • Active comparator
    combined monitoring

    Procedure: ultrasound · Procedure: combined monitoring

Interventions

  • Procedureultrasound
  • Procedurecombined monitoring
06

What researchers measure

Primary outcomes

  1. The number of mature oocytes obtained.

    Time frame: 1 day

Secondary outcomes

  1. The number of fertilized oocytes/good quality embryos

    Time frame: at the moment of egg retrieval up to embryo transfer, assessed up to 100 months

  2. Pregnancy rate

    Time frame: 12 months after egg retrieval

  3. clinical pregnancy rate

    Time frame: 12 months after egg retrieval

  4. ongoing pregnancy rate

    Time frame: 12 months after egg retrieval

  5. live birth rate for each individual transferred embryo

    Time frame: 12 months after egg retrieval

07

Study locations

1 site
  • University Hospital
    Ghent, 9000, Belgium
08

References and documents

Publications

  • Vandekerckhove F, Gerris J, Vansteelandt S, De Baerdemaeker A, Tilleman K, De Sutter P. Delaying the oocyte maturation trigger by one day leads to a higher metaphase II oocyte yield in IVF/ICSI: a randomised controlled trial. Reprod Biol Endocrinol. 2014 Apr 23;12:31. doi: 10.1186/1477-7827-12-31. PubMed 24758641 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01980563
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Nov 11, 2013
Start date
Jan 2011
Primary completion
Dec 2011
Completion
Dec 2012
Last update
Nov 11, 2013

Study contacts

Frank Vandekerckhove, MD
principal investigator · Fertility clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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