An observational study in Beta-hCG Positivity, Clinical Pregnancy and Miscarriage, sponsored by Duzce University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 23 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Duzce University · Observational
This study aims to compare the In Vitro Fertilization (IVF/ICSI) outcomes of patients with a sperm concentration of \<5 million/mL (severe oligozoospermia) and \<1 million/mL (cryptozoospermia) to those diagnosed with nonobstructive azoospermia (NOA). Men are categorized into three groups: NOA, cryptozoospermia (CRYP), and severe oligozoospermia (SO). These three groups are compared in terms of beta-hCG positivity, clinical pregnancy rate, live birth rate, and early pregnancy loss.
Objective: This study aimed to compare the In Vitro Fertilization (IVF/ICSI) outcomes of patients with a sperm concentration of \<5 million/mL (severe oligozoospermia) and \<1 million/mL (cryptozoospermia) and those diagnosed with nonobstructive azoospermia (NOA).
Materials and Methods: The data of patients who underwent IVF solely due to male factor infertility among 1,430 patient files admitted to the Ankara Bilkent City Hospital Assisted Reproductive Technology Center between 2019 and September 2023 were retrospectively evaluated. Based on semen analysis results, patients categorized into three groups: NOA, cryptozoospermia (CRYP), and severe oligozoospermia (SO). These three groups were compared in terms of ovarian stimulation characteristics and IVF outcomes, including beta-hCG positivity, clinical pregnancy rate, live birth rate, and early pregnancy loss.
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Data from 1,430 patient files who applied to the Assisted Reproductive Treatment Center of Ankara Bilkent City Hospital between November 2019 and September 2023, were evaluated retrospectively. Among these, data from 80 men with no detected major or minor chromosomal anomalies, including Y-chromosome microdeletions, who were admitted to the assisted reproductive technology (ART) program solely due to male infertility, were analyzed. Patients were divided into three groups based on their spermiogram results: Non-obstructive azoospermia (NOA Group), sperm concentration ≤1 million/mL (CRYP Group), and sperm concentration 1-5 million/mL (SO Group). Data for the study cohort were obtained via a retrospective review of hospital and clinic registries.
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Exclusion Criteria:
cryptozoospermia (CRYP)
beta-hCG positivity
\<20 serum beta-hCG level
Time frame: 4 years
ongoing pregnancy
Detection of fetal cardiac activity on ultrasound
Time frame: 4 years
live birth rate
live birth \> 24 weeks of gestation
Time frame: 4 years
Plan to share: Yes — Demographic data of women and controlled ovarian stimulation parameters-including age, body mass index (BMI), gravidity, parity, systemic diseases, smoking status, duration of infertility, number of previous IVF failures, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), serum AMH level, antral follicle count (AFC), total gonadotropin dose, and duration of ovulation induction- Trigger day parameters (peak estradiol and progesterone levels, endometrial thickness, and number of follicles > 14 mm) and embryological data (numbers of retrieved, mature [MII], and fertilized oocytes, total embryo yield, and the specific day, grade, and number of transferred embryos) . Clinical ART outcomes as beta-hCG positivity, clinical pregnancy rates (CPR), early pregnancy losses, and live birth rates (LBR).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 24.06.2026-24.06.2036
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Duzce University