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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follicular Flushing in Patients With Mono-follicular Growth

Conditions
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Invitro Fertilization, Diminished Ovarian Reserve, Oocyte

Intervention / Treatment
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* Behavioral: direct follicular aspiration
* Behavioral: follicular flushing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| direct aspiration group<br>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. | Behavioral: direct follicular aspiration<br>* direct follicular aspiration<br>|
| flushing group<br>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. | Behavioral: follicular flushing<br>* follicular flushing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follicular flushing, double lumen needle