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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04131452
Other study ID # Bahceci Mehmet Asoglu
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date December 2020

Study information

Verified date January 2020
Source Bahceci Health Group
Contact Mehmet Resit Asoglu, Ass. Prof
Phone +90 530 923 83 16
Email mresitasoglu@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 transfer.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 232
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 39 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Filling out the forms including IDAS-II, BAI, SF-36 and FSFI
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).

Locations

Country Name City State
Turkey Bahceci Health Group Istanbul Sisli

Sponsors (2)

Lead Sponsor Collaborator
Bahceci Health Group Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Purewal 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 Ma — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Clinical pregnancy is defined as the presence of intrauterine fetal heartbeat at around 7 weeks of gestation. At around 7 weeks of gestation
Secondary Implantation rate Implantation is defined as presence of intrauterine gestational sac at around 6 weeks of gestation. At around 6 weeks of gestation
Secondary Live birth rate Live birth is defined as at least a live birth after 24 completed weeks of gestation. 24 completed weeks of gestation
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