Clinical trial NCT04131452: Women's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo Transfers
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Anxiety State
Depression
Quality of Life
Sexual Function and Fertility Disorders
Lead sponsor: Bahceci Health Group
Sponsor class: OTHER
Collaborators: name: Uskudar University
First posted: 2019-10-18
Enrollment: 232
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of women undergoing fresh or frozen embryo transfer after assisted reproductive treatment.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: At around 7 weeks of gestation
Secondary outcomes:
measure: Implantation rate
timeFrame: At around 6 weeks of gestation
measure: Live birth rate
timeFrame: 24 completed weeks of gestation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceci Health Group
state: Sisli
Study officials:
affiliation: Bahceci Health Group
name: Mehmet Resit Asoglu, Ass, prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Mar 23.