HCG Day Follicle Diameter, Reproduction ResultsNCT04679688
Comparison of Follicle Diameter on hCG Day and Follicle Diameters on OPU (Oocyte Pick up) Day and the Effect of Follicle Diameters on Embryo Development and Pregnancy Outcomes
A study testing descriptive in people with HCG Day Follicle Diameter, Reproduction Results, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Evaluation of follicle diameters on human chorionic gonadotrophin(hCG) day and oocyte pick up (OPU) day of follicles developing after gonadotropin treatment, the relationship between follicle diameter and maturation in oocytes obtained after OPU and its effect on pregnancy outcomes will be investigated. Read more about this study
- Who is it for?
- Ages 23 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HCG Day Follicle Diameter, Reproduction Results
- What is being tested?
- descriptive
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 20 Dec 2021
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient group with at least 5 and at most 10 follicles in each ovary whose hCG day exceeds 11 mm,
- Patient group with BMI below 30.
Who cannot join
- PCO patient group,
- Male factor group with severe OAT,
- Patient group with endometriosis,
- Patient group with PGD indication,
- The group under the age of 40 and legally deserving of double embryo transfer
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Acıbadem University Atakent Hospital
Istanbul, Küçükçekmece, 34303
Turgut Aydın, 0905323722713, drturgutaydin@hotmail.com
- Active, not recruiting
Acibadem MAA University Atakent Hospital
Istanbul, 34457
About this study
Official title: Acıbadem University Medical Faculty Atakent Hospital IVF Unit
Evaluation of follicle diameters on human chorionic gonadotrophin(hCG) day and oocyte pick up (OPU) day of follicles developing after gonadotropin treatment, the relationship between follicle diameter and maturation in oocytes obtained after OPU and its effect on pregnancy outcomes will be investigated. In order to make it easier to measure and enumerate the follicle diameters with the help of vaginal ultrasound, patients under 35 years of age with at most five follicles in any ovary and at least four follicles in both ovaries will be included in the study.
Read the detailed description
In our study, patients with 5 and 10 follicles exceeding 11 mm will be included in order to define the follicles whose hCG day is measured more clearly on the day of OPU in patients with whom we performed controlled ovarian hyperstimulation for in vitro fertilisation(IVF). The localizations and diameters of these follicles in both ovaries will be drawn and the hCG day will be numbered and their measurements will be indicated. On the day of opu, the marked and numbered follicles will be measured, noted and aspirated one by one, the collected eggs will be followed in individually numbered culture dish and it will be evaluated whether they are mature or not prepared for microinjection. And mature oocytes will be followed in numbered culture dishes after microinjection. The relationship between hCG and OPU day follicle diameter will be evaluated by following the follicle diameter and follicle diameters on the day of egg collection, the relationship between the mature egg, the rate of reaching the blastocyst stage, the clinical pregnancy and live birth rates
Especially the relationship between mature egg and follicle diameter and the resulting clinical results may guide clinicians in practice.
- Being tested
- descriptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiveOther
Also called The effect of follicle diameters on embryo development and pregnancy outcomes.
Those who apply for IVF treatment and have an antral follicle number of 4-10 will be included in the treatment. The reason for including patients with this number of antral follicles in the study is to determine the follicle locations and to determine each growing follicle separately on the day of hCG and egg collection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
live birth rate of participants
Measured: 15 months
Clinical pregnancy rate
clinical pregnancy rate of participants
Measured: 6 months
Secondary outcomes (1)
Oocyte maturation
Oocyte maturation rate of participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start20 Dec 2020
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCG Day Follicle Diameter, Reproduction ResultsStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679688
- Sponsor's protocol ID
- ATAKIVF
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acıbadem University Medical Faculty Atakent Hospital IVF Unit
- ClinicalTrials.gov ID
- NCT04679688
- Acronym / sponsor ID
- ATAKIVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 22 Dec 2020 (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.
Evaluation of follicle diameters on human chorionic gonadotrophin(hCG) day and oocyte pick up (OPU) day of follicles developing after gonadotropin treatment, the relationship between follicle diameter and maturation in oocytes obtained after OPU and its effect on pregnancy outcomes will be investigated. In order to make it easier to measure and enumerate the follicle diameters with the help of vaginal ultrasound, patients under 35 years of age with at most five follicles in any ovary and at least four follicles in both ovaries will be included in the study.
Detailed description
In our study, patients with 5 and 10 follicles exceeding 11 mm will be included in order to define the follicles whose hCG day is measured more clearly on the day of OPU in patients with whom we performed controlled ovarian hyperstimulation for in vitro fertilisation(IVF). The localizations and diameters of these follicles in both ovaries will be drawn and the hCG day will be numbered and their measurements will be indicated. On the day of opu, the marked and numbered follicles will be measured, noted and aspirated one by one, the collected eggs will be followed in individually numbered culture dish and it will be evaluated whether they are mature or not prepared for microinjection. And mature oocytes will be followed in numbered culture dishes after microinjection. The relationship between hCG and OPU day follicle diameter will be evaluated by following the follicle diameter and follicle diameters on the day of egg collection, the relationship between the mature egg, the rate of reaching the blastocyst stage, the clinical pregnancy and live birth rates
Especially the relationship between mature egg and follicle diameter and the resulting clinical results may guide clinicians in practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 23 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient group with at least 5 and at most 10 follicles in each ovary whose hCG day exceeds 11 mm,
- Patient group with BMI below 30.
Key exclusion criteria (5 listed)
- PCO patient group,
- Male factor group with severe OAT,
- Patient group with endometriosis,
- Patient group with PGD indication,
- The group under the age of 40 and legally deserving of double embryo transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| descriptiveAlso: The effect of follicle diameters on embryo development and pregnancy outcomes.Those who apply for IVF treatment and have an antral follicle number of 4-10 will be included in the treatment. The reason for including patients with this number of antral follicles in the study is to determine the follicle locations and to determine each growing follicle separately on the day of hCG and egg collection. | Other | – |
Primary outcome
Live birth rate
Time frame: 15 months
live birth rate of participants
Clinical pregnancy rate
Time frame: 6 months
clinical pregnancy rate of participants
1 secondary outcome
Oocyte maturation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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.
Acıbadem University Atakent Hospital
Istanbul, Turkey (Türkiye)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing descriptive in people with HCG Day Follicle Diameter, Reproduction Results, run by Acibadem University at 2 sites 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.