Clinical trial NCT03831542: Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
Official title: Follicular Flushing in Patients With Mono-follicular Growth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invitro Fertilization
Diminished Ovarian Reserve
Oocyte
Keywords: follicular flushing
double lumen needle
Lead sponsor: Centrum Clinic IVF Center
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing oocyte retrieval procedure due to primary infertility

Brief summary: Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Flushing the follicle with multiple aspirations from the same follicle is used as a means to increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not superior to direct aspiration either in normally responding patients or in poor responders undergoing in vitro fertilization (IVF). There is no data in the literature regarding the issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the follicle for those with a single follicle will be investigated.

Detailed description: Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing during oocyte retrieval procedure in patients with only one follicle. Double lumen needle will be used and direct follicular aspiration without flushing will be performed for all patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at least 1 course of follicular flushing will be used until retrieval of an oocyte and the patient will be assigned to group B.

Eligibility criteria: Inclusion Criteria:

* women aged 18-40 years
* primary infertility
* diminished ovarian reserve with single mature follicle on the day of oocyte retrieval

Exclusion Criteria:

* natural cycle IVF
* presence of endometriosis/endometrioma(s)
* Absence of cumulus oocyte complex following oocyte retrieval
* Severe male factor infertility
* Pre-implantation genetic screening cycles

Primary outcomes:
measure: mature oocyte
timeFrame: during oocyte retrieval procedure
Secondary outcomes:
measure: fertilization rate after micro-injection
timeFrame: 24 hours after microinjection procedure
measure: clinical pregnancy rate per embryo transfer
timeFrame: untill 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Centrum Clinic IVF Center
Study officials:
affiliation: Centrum Clinic IVF Center
name: Emre Pabuccu, MD
role: STUDY_DIRECTOR
References:
citation: von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.
citation: Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.