Does Follicular Flushing Improve the Outcome in Monofollicular IVF Therapy?

NCT02641808 | Completed Phase 3 DMC

• 1 other identifier: 2015-00150
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

Follicular aspiration as well as follicular flushing are standardized techniques and have been practiced in polyfollicular IVF (in vitro fertilization) therapy for years. Monofollicular IVF therapy is a standard technique as well. IVF can be done in natural cycles or with a minimal stimulation with clomifen citrate to achieve a monofollicular response. Our study aims to compare follicular aspiration and follicular flushing in monofollicular stimulation. First the investigators want to answer the question whether flushing is beneficial for the oocyte yield. In case of a positive result the investigators want to establish a recommendation about the optimal number of flushings taking into account the duration of the procedure and the pain during manipulation.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Proportion of mature oocytes retrieved

  day of intervention

Secondary Outcomes (7)

• Number of flushings necessary to retrieve the oocyte (intervention arm only)

  day of intervention

• Fertilisation rate

  one day after intervention

• Embryo quality (BLEFCO and ASEBIR score) on day 2 after fertilisation

  two days after intervention

• Transfer rate

  2-3 days after intervention

• Pregnancy rate

  up to 9 months after the intervention

Study Arms (2)

follicular flushing group

EXPERIMENTAL

Monofollicular IVF therapy with follicular flushing up to five times after aspiration of the follicule at the time to the oocyte pick-up

Other: follicular flushing

aspiration group

ACTIVE COMPARATOR

Monofollicular IVF therapy with aspiration only at the time of the oozyte pick-up

Other: no follicular flushing

Interventions

follicular flushing OTHER

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.

follicular flushing group

no follicular flushing OTHER

aspiration group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Indication for in vitro Fertilisation
• Desire of natural cycle IVF and ICSI fertilisation
• Regular menstrual cycle, both ovaries can be reached for follicule aspiration
• years
• size of the follicle ≥16mm
• max. 2 previous embryo transfers

You may not qualify if:

• \<18 and \>42 years
• Preterm ovulation
• \>= 3 previous embryo transfers

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Related Publications (1)

• Kohl Schwartz AS, Calzaferri I, Roumet M, Limacher A, Fink A, Wueest A, Weidlinger S, Mitter VR, Leeners B, Von Wolff M. Follicular flushing leads to higher oocyte yield in monofollicular IVF: a randomized controlled trial. Hum Reprod. 2020 Oct 1;35(10):2253-2261. doi: 10.1093/humrep/deaa165.

  PMID: 32856073 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Alexandra S Kohl Schwartz, MD

  Reproductive Endocrinologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 29, 2015
• Study Start: August 1, 2016
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share