Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization

Diminished Ovarian Reserve Clinical Trial

Official title:

Follicular Flushing in Patients With Mono-follicular Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831542
• Other study ID #: 1
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: May 2019
• Source: Centrum Clinic IVF Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 6, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Flushing
• Invitro Fertilization
• Oocyte

Intervention

Behavioral:
• direct follicular aspiration
direct follicular aspiration
• follicular flushing
follicular flushing

Locations

Country	Name	City	State
Turkey	Centrum Clinic IVF Center	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Centrum Clinic IVF Center

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mature oocyte	Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.	during oocyte retrieval procedure
Secondary	fertilization rate after micro-injection	Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.	24 hours after microinjection procedure
Secondary	clinical pregnancy rate per embryo transfer	Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.	untill 6 weeks