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

Completed

• Conditions: Invitro Fertilization; Oocyte; Diminished Ovarian Reserve
• Interventions: Behavioral: direct follicular aspiration; Behavioral: follicular flushing

• Registration Number: NCT03831542
• Lead Sponsor: Centrum Clinic IVF Center

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.

Study Timeline

• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Study Start: 2019-02-19
• Status Verified: 2019-05
• Primary Completion: 2019-05-05
• Study Completion: 2019-05-06
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
direct aspiration group	direct follicular aspiration	Transvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing.
flushing group	follicular flushing	If an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing.

Primary Outcome Measures

Name	Time	Method
mature oocyte	during oocyte retrieval procedure	Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.

Secondary Outcome Measures

Name	Time	Method
fertilization rate after micro-injection	24 hours after microinjection procedure	Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.
clinical pregnancy rate per embryo transfer	untill 6 weeks	Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.

Trial Locations

Locations (1)

Centrum Clinic IVF Center; 🇹🇷 Ankara, Turkey