Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Study Overview
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Brief Summary
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The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI). This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.

Official Title
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Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study

Conditions
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Female Infertility

Intervention / Treatment
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* Procedure: Intracytoplasmic sperm injection (ICSI)
* Procedure: Intracytoplasmic morphologically selected sperm injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good physical and mental health Advanced maternal age (≥ 37 years old) Regular menstrual cycles of 25-35 days Normal basal FSH and LH levels Body mass index less than 30 kg/m2 Presence of both ovaries Intact uterus No hormone therapy for at least 60 days preceding the study Exclusion Criteria: Polycystic ovaries Endometriosis Gynaecological/medical disorders Positive result in a screening for sexually transmitted diseases

Ages Eligible for Study
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Minimum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICSI group<br>This group was provided with conventional intracytoplasmic sperm injection (ICSI). This treatment is routinely used to treat infertility. Sperm selection in the ICSI group is analysed under a magnification of 400x using an inverted microscope. | Procedure: Intracytoplasmic sperm injection (ICSI)<br>* ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.<br>|
| Experimental: Intracytoplasmic morphologically selected sperm injection<br>Intracytoplasmic morphologically selected sperm injection (IMSI) is an established modified ICSI procedure. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection. | Procedure: Intracytoplasmic morphologically selected sperm injection<br>* IMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Number of embryos implanted in the uterus divided for the number of embryos transferred. | 6 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced maternal age, infertility, IMSI, ICSI, implantation