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

• Conditions: Depression; Quality of Life; Sexual Function and Fertility Disorders; Anxiety State; Infertility, Female
• Interventions: Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFI

• Registration Number: NCT04131452
• Lead Sponsor: Bahceci Health Group

Brief 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.

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 Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Study Start: 2020-01-20
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 232

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fresh embryo transfers	Filling out the forms including IDAS-II, BAI, SF-36 and FSFI	those undergoing fresh embryo transfer
Frozen embryo transfers	Filling out the forms including IDAS-II, BAI, SF-36 and FSFI	those undergoing frozen embriyo transfer

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	At around 7 weeks of gestation	Clinical pregnancy is defined as the presence of intrauterine fetal heartbeat at around 7 weeks of gestation.

Secondary Outcome Measures

Name	Time	Method
Live birth rate	24 completed weeks of gestation	Live birth is defined as at least a live birth after 24 completed weeks of gestation.
Implantation rate	At around 6 weeks of gestation	Implantation is defined as presence of intrauterine gestational sac at around 6 weeks of gestation.

Trial Locations

Locations (1)

Bahceci Health Group; 🇹🇷 Istanbul, Sisli, Turkey