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Optimizing Ovarian Stimulation for IVF and ICSI

NCT ID: NCT01980563

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Efficiency in Terms of Mature Oocyte Yield

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasound

Group Type ACTIVE_COMPARATOR

ultrasound

Intervention Type PROCEDURE

combined monitoring

Intervention Type PROCEDURE

combined monitoring

Group Type ACTIVE_COMPARATOR

ultrasound

Intervention Type PROCEDURE

combined monitoring

Intervention Type PROCEDURE

Interventions

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ultrasound

Intervention Type PROCEDURE

combined monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* absence of ovarian cysts
* both ovaries present

Exclusion Criteria

* ovarian cysts
* not both ovaries present
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Vandekerckhove, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility clinic

Locations

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University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24758641 (View on PubMed)

Other Identifiers

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EC/2010/367

Identifier Type: -

Identifier Source: org_study_id