- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641808
Does Follicular Flushing Improve the Outcome in Monofollicular IVF Therapy? (Flushing)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is an increase in mono- and oligofollicular IVF therapies worldwide. With the increase in oligo- and monofollicular IVF techniques, a re-evaluation of the aspiration techniques is necessary. The lower the number of mature follicules, the higher the need to obtain the oocyte. The number of embryos obtained is dependent on the number of oocytes retrieved (Wood 2000).
Von Wolff et al. showed (2013) that, three flushings almost doubled not only the number of aspirated oocytes but also the transfer rate in monofollicular IVF. Oocytes, collected by flushing, were as mature and fertilizable as those aspirated without flushing. Mendez Lozano et al. performed an aspiration without flushing in 79 women and with triple flushing in 47 women. They were stimulated with HMG (human menopausal gonadotropin) and controlled with GnRH (Gonadotropin releasing hormone) antagonists in a semi natural cycle IVF. The percentage of patients with a good embryo was 28.8% in the group without flushing and 37.8% in the group with flushing; however, the difference was not significant. Women with an indication for an IVF therapy and the wish of natural cycle IVF are randomized to the intervention (flushing) or control arm (no flushing). In natural cycle IVF, there is no gonadotropin stimulation. Clomifen citrate (25mg e.g. Serophene®, Merck Serono, from the 6th day of cycle) or singles doses of GnRH-antagonists (e.g. Orgalutran®, MSD, Merck Sharp & Dohme AG) are only given to avoid premature ovulation. Once maturity of the follicle is achieved (follicle size ≥16mm), 5000IU urinary human chorionic gonadotropin (uHCG) is used to trigger ovulation. Oocyte pickup (OPU) is performed 36.5 (36-37) hours after ovulation induction. No anesthesia is used for this procedure. For the aspiration 19 gauge single lumen needles are used. After the aspiration the needle is removed and flushed. Depending on randomisation the follicle is not flushed (group A) or flushed adapted to follicule size (16mm 2ml, 18mm 3ml, and 20mm 4ml etc.) up to five times with (e.g.flushing media with heparin (SynVitro® Flush, Origio, Berlin, Germany). In case more than 1 follicle develops, only the largest follicle is analysed. The flushings are collected each in a separate collecting tube (group B). The analysis of the collected oocytes is performed in the IVF lab. The aspirated fluid is analyzed in the IVF lab by the independent biologist. Pain is monitored by VAS (visual analogue scale) score and time of intervention is measured. In the IVF lab the oocytes are fertilised by ICSI (intracytoplasmatic sperm injection) and the embryo transferred 2-3 days later.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Indication for in vitro Fertilisation
- Desire of natural cycle IVF and ICSI fertilisation
- Regular menstrual cycle, both ovaries can be reached for follicule aspiration
- 18-42 years
- size of the follicle ≥16mm
- max. 2 previous embryo transfers
Exclusion Criteria:
- <18 and >42 years
- Preterm ovulation
- >= 3 previous embryo transfers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: follicular flushing group
Monofollicular IVF therapy with follicular flushing up to five times after aspiration of the follicule at the time to the oocyte pick-up
|
Depending on randomisation the follicle is not flushed (group A) or flushed adapted to follicule size (16mm 2ml, 18mm 3ml, and 20mm 4ml etc.) up to five times with (e.g.flushing media with heparin (SynVitro® Flush, Origio, Berlin, Germany).
The flushings are collected each in a separate collecting tube (group B).
The analysis of the collected oocytes is performed in the IVF lab.
|
Active Comparator: aspiration group
Monofollicular IVF therapy with aspiration only at the time of the oozyte pick-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of mature oocytes retrieved
Time Frame: day of intervention
|
day of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of flushings necessary to retrieve the oocyte (intervention arm only)
Time Frame: day of intervention
|
day of intervention
|
Fertilisation rate
Time Frame: one day after intervention
|
one day after intervention
|
Embryo quality (BLEFCO and ASEBIR score) on day 2 after fertilisation
Time Frame: two days after intervention
|
two days after intervention
|
Transfer rate
Time Frame: 2-3 days after intervention
|
2-3 days after intervention
|
Pregnancy rate
Time Frame: up to 9 months after the intervention
|
up to 9 months after the intervention
|
Pain during intervention measured on a VAS scale
Time Frame: day of intervention
|
day of intervention
|
Time used for intervention
Time Frame: day of intervention
|
day of intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexandra S Kohl Schwartz, MD, Reproductive Endocrinologist
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-00150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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