Beta-hCG PositivityARTNCT07897279
Evaluation of Assisted Reproductive Technology (ART) Outcomes in Couples With Nonobstructive Azoospermia, Cryptozoospermia, and Severe Oligozoospermia
An observational study of Beta-hCG Positivity and Clinical Pregnancy, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 23 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta-hCG Positivity, Clinical Pregnancy, Miscarriage
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Men admitted to the assisted reproductive technology (ART) program solely due to male infertility
- No detected major or minor chromosomal anomalies, including Y-chromosome microdeletions
- Diagnosis of nonobstructive azoospermia, cryptozoospermia, or severe oligozoospermia
Who cannot join
- Female partner age under 23 or over 43 years
- Presence of documented female infertility factors (such as tubal occlusion, diminished ovarian reserve, ovulatory dysfunction, or unexplained infertility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Assisted Reproductive Treatment Center of Ankara Bilkent City Hospital
Ankara
About this study
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.
Read the detailed description
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.
- Conditions
- Beta-hCG Positivity, Clinical Pregnancy, Miscarriage, Multiple Pregnancy, Ongoing Pregnancy, Live Birth Rates
- Keywords
- cryptozoospermia, In Vitro Fertilization, nonobstructive azoospermia, severe oligozoospermia
- Medical subject headings
- Abortion, Spontaneous, Oligospermia, Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| nonobstructive azoospermia (NOA) | cryptozoospermia (CRYP) | |
| severe oligozoospermia (SO) | Not described | |
| cryptozoospermia (CRYP) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta-hCG positivity
<20 serum beta-hCG level
Measured: 4 years
ongoing pregnancy
Detection of fetal cardiac activity on ultrasound
Measured: 4 years
live birth rate
live birth > 24 weeks of gestation
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2019
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Beta-hCG PositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Collaborators
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
- Responsible party
- Principal investigator, Ali Yavuzcan, Duzce University
- Investigators
- Merve Tepecik, Principal investigator, Çankırı State HospitalZehra Kurdoğlu, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897279
- Sponsor's protocol ID
- E2-23-5038
- Acronym
- ART
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Datta AK, Campbell S, Diaz-Fernandez R, Nargund G. Livebirth rates are influenced by an interaction between male and female partners' age: analysis of 59 951 fresh IVF/ICSI cycles with and without male infertility. Hum Reprod. 2024 Nov 1;39(11):2491-2500. doi: 10.1093/humrep/deae198.
PubMed 39241250
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Assisted Reproductive Technology (ART) Outcomes in Couples With Nonobstructive Azoospermia, Cryptozoospermia, and Severe Oligozoospermia
- ClinicalTrials.gov ID
- NCT07897279
- Acronym / sponsor ID
- ART / E2-23-5038
- Conditions
- Beta-hCG Positivity, Clinical Pregnancy, Miscarriage, Multiple Pregnancy, Ongoing Pregnancy, Live Birth Rates
- Keywords
- cryptozoospermia, In Vitro Fertilization, nonobstructive azoospermia, severe oligozoospermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Collaborators
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nonobstructive azoospermia (NOA) | – | –cryptozoospermia (CRYP) |
| severe oligozoospermia (SO) | – | – |
| cryptozoospermia (CRYP) | – | – |
Who may qualify
- Ages
- 23 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Men admitted to the assisted reproductive technology (ART) program solely due to male infertility
- No detected major or minor chromosomal anomalies, including Y-chromosome microdeletions
- Diagnosis of nonobstructive azoospermia, cryptozoospermia, or severe oligozoospermia
Key exclusion criteria (2 listed)
- Female partner age under 23 or over 43 years
- Presence of documented female infertility factors (such as tubal occlusion, diminished ovarian reserve, ovulatory dysfunction, or unexplained infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
beta-hCG positivity
Time frame: 4 years
<20 serum beta-hCG level
ongoing pregnancy
Time frame: 4 years
Detection of fetal cardiac activity on ultrasound
live birth rate
Time frame: 4 years
live birth > 24 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 39241250Datta AK, Campbell S, Diaz-Fernandez R, Nargund G. Livebirth rates are influenced by an interaction between male and female partners' age: analysis of 59 951 fresh IVF/ICSI cycles with and without male infertility. Hum Reprod. 2024 Nov 1;39(11):2491-2500. doi: 10.1093/humrep/deae198.
- Individual participant dataSharing planned: 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).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Tepecik principal investigator
Çankırı State Hospital
Zehra Kurdoğlu study director
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta-hCG Positivity and Clinical Pregnancy, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beta-hCG positivity (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.