Women's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo Transfers

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131452
• Other study ID #: Bahceci Mehmet Asoglu
• Status: Not yet recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Anxiety State
• Depression
• Infertility
• Infertility, Female
• Quality of Life
• Sexual Function and Fertility Disorders

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