Infertility, FemaleNCT04131452
Women's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo Transfers
An observational study of Infertility, Female and Anxiety State, run by Bahceci Health Group at 1 site in Turkey (Türkiye).
Trial summary
Women's quality of life, sexual life and psychological state would affect the success of embryo transfer. The primary purpose of the study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Anxiety State, Depression
- What is being tested?
- Filling out the forms including IDAS-II, BAI, SF-36 and FSFI
- How many people
- 232 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to Dec 2020
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population will consist of women undergoing fresh or frozen embryo transfer after assisted reproductive treatment.
Who may be able to join
- Age between 20 - 39 years
- Body mass index between 18 -3 5 kg/m2
- Anti-mullerian hormone levele >1.1 ng/ml or antral follicle count > 8
- fresh or frozen embryo transfer using middle-quality or good-quality day 3 or 5 embryos
Who cannot join
- Age below 20 or over 39 years
- Uterine malformations
- Hypo or hyperthyroidism
- Diabetes mellitus
- Previous history of psychiatric disorders
- Use of psychiatric medications
- Systemic disorders (hypertension, chronic liver/kidney/heart problems)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahceci Health Group
Istanbul, Sisli, 34394
Mehmet Resit Asoglu, Ass, prof, +90 530 923 83 16, mresitasoglu@hotmail.com
Cem Celik, Prof, +90 532 420 53 65, cemcel@yahoo.com
About this study
Official title: Do Women's Quality of Life, Sexual Life and Psychological State Differ Between Patients Undergoing Fresh and Frozen Embryo Transfers: a Prospective Study
Women's quality of life, sexual life and psychological state would affect the success of embryo transfer. The primary purpose of the study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer.
Read the detailed description
There are two types of embryo transfers; fresh and frozen embryo transfers. Studies have been conducted to compare success rates between fresh and frozen embryo transfers. However, most studies have not taken into consideration women's quality of life, sexual life and psychological state in comparing fresh embryo transfer with frozen embryo transfers. These all parameters are confounding factors that may influence the success of embryo transfer. The purpose of this study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer. The following forms will be used: expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI. This study can provide evidence regarding the association between women's quality of life, sexual life and psychological state and embryo transfer success.
- Conditions
- Infertility, Female, Anxiety State, Depression, Quality of Life, Sexual Function and Fertility Disorders
- Being tested
- Filling out the forms including IDAS-II, BAI, SF-36 and FSFI
- Medical subject headings
- Infertility, Female, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling out the forms including IDAS-II, BAI, SF-36 and FSFIOther
Participants will fill out certain validated forms including the expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI).
| Study group | Role | What they receive |
|---|---|---|
| Fresh embryo transfers | those undergoing fresh embryo transfer Receives: Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFI | |
| Frozen embryo transfers | those undergoing frozen embriyo transfer Receives: Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy is defined as the presence of intrauterine fetal heartbeat at around 7 weeks of gestation.
Measured: At around 7 weeks of gestation
Secondary outcomes (2)
Implantation rate
Implantation is defined as presence of intrauterine gestational sac at around 6 weeks of gestation.
Measured: At around 6 weeks of gestation
Live birth rate
Live birth is defined as at least a live birth after 24 completed weeks of gestation.
Measured: 24 completed weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start20 Jan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahceci Health Group
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Mehmet Resit Asoglu, Bahceci Health Group
- Investigators
- Mehmet Resit Asoglu, Ass, prof, Principal investigator, Bahceci Health Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131452
- Sponsor's protocol ID
- Bahceci Mehmet Asoglu
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skvirsky V, Taubman-Ben-Ari O, Ben Shlomo S, Azuri J, Horowitz E. Contributors to Women's Perceived Stress at the Start of Assisted Reproductive Technology. J Psychol. 2019;153(1):23-36. doi: 10.1080/00223980.2018.1471037. Epub 2018 Sep 13.
PubMed 30211664Purewal S, Chapman SCE, van den Akker OBA. Depression and state anxiety scores during assisted reproductive treatment are associated with outcome: a meta-analysis. Reprod Biomed Online. 2018 Jun;36(6):646-657. doi: 10.1016/j.rbmo.2018.03.010. Epub 2018 Mar 23.
PubMed 29622404
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Women's Quality of Life, Sexual Life and Psychological State Differ Between Patients Undergoing Fresh and Frozen Embryo Transfers: a Prospective Study
- ClinicalTrials.gov ID
- NCT04131452
- Acronym / sponsor ID
- Bahceci Mehmet Asoglu
- Conditions
- Infertility, Female, Anxiety State, Depression, Quality of Life, Sexual Function and Fertility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Bahceci Health GroupUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 20 Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Oct 2019 (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.
Women's quality of life, sexual life and psychological state would affect the success of embryo transfer. The primary purpose of the study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer.
Detailed description
There are two types of embryo transfers; fresh and frozen embryo transfers. Studies have been conducted to compare success rates between fresh and frozen embryo transfers. However, most studies have not taken into consideration women's quality of life, sexual life and psychological state in comparing fresh embryo transfer with frozen embryo transfers. These all parameters are confounding factors that may influence the success of embryo transfer. The purpose of this study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer. The following forms will be used: expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI. This study can provide evidence regarding the association between women's quality of life, sexual life and psychological state and embryo transfer success.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh embryo transfers | – | Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFIthose undergoing fresh embryo transfer |
| Frozen embryo transfers | – | Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFIthose undergoing frozen embriyo transfer |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population will consist of women undergoing fresh or frozen embryo transfer after assisted reproductive treatment.
Key inclusion criteria (4 listed)
- Age between 20 - 39 years
- Body mass index between 18 -3 5 kg/m2
- Anti-mullerian hormone levele >1.1 ng/ml or antral follicle count > 8
- fresh or frozen embryo transfer using middle-quality or good-quality day 3 or 5 embryos
Key exclusion criteria (7 listed)
- Age below 20 or over 39 years
- Uterine malformations
- Hypo or hyperthyroidism
- Diabetes mellitus
- Previous history of psychiatric disorders
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 |
|---|---|---|
| Filling out the forms including IDAS-II, BAI, SF-36 and FSFIParticipants will fill out certain validated forms including the expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI). | Other | Fresh embryo transfers, Frozen embryo transfers |
Primary outcome
Clinical pregnancy rate
Time frame: At around 7 weeks of gestation
Clinical pregnancy is defined as the presence of intrauterine fetal heartbeat at around 7 weeks of gestation.
2 secondary outcomes
Implantation rate
Time frame: At around 6 weeks of gestation
Live birth rate
Time frame: 24 completed weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Results publication: PubMed 30211664Skvirsky V, Taubman-Ben-Ari O, Ben Shlomo S, Azuri J, Horowitz E. Contributors to Women's Perceived Stress at the Start of Assisted Reproductive Technology. J Psychol. 2019;153(1):23-36. doi: 10.1080/00223980.2018.1471037. Epub 2018 Sep 13.
- Results publication: PubMed 29622404Purewal S, Chapman SCE, van den Akker OBA. Depression and state anxiety scores during assisted reproductive treatment are associated with outcome: a meta-analysis. Reprod Biomed Online. 2018 Jun;36(6):646-657. doi: 10.1016/j.rbmo.2018.03.010. Epub 2018 Mar 23.
- Individual participant dataSharing planned: No
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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.
Mehmet Resit Asoglu, Ass, prof principal investigator
Bahceci Health Group
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 Infertility, Female and Anxiety State, run by Bahceci Health Group 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 4 inclusion and 7 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 18 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Resit Asoglu, Ass. Prof (+90 530 923 83 16, mresitasoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: At around 7 weeks of gestation). 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 NCT04131452, which also lists 2 linked publications.
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 18 Jan 2020.