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

Sponsor

Bahceci Health Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT04131452

Collaborator

Uskudar University (Other)

232

Enrollment

Location

10.4

Anticipated Duration (Months)

22.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Anxiety State Depression Quality of Life Sexual Function and Fertility Disorders	Other: Filling out the forms including IDAS-II, BAI, SF-36 and FSFI

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

Study Type:

Observational

Anticipated Enrollment :

232 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jan 20, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Fresh embryo transfers those undergoing fresh embryo transfer	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).
Frozen embryo transfers those undergoing frozen embriyo transfer	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).

Arm

Intervention/Treatment

Fresh embryo transfers

those undergoing fresh embryo transfer

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).

Frozen embryo transfers

those undergoing frozen embriyo transfer

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bahceci Health Group	Istanbul	Sisli	Turkey	34394

Sponsors and Collaborators

Bahceci Health Group
Uskudar University

Investigators

Principal Investigator: Mehmet Resit Asoglu, Ass, prof, Bahceci Health Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet Resit Asoglu, Associate professor, Bahceci Health Group

ClinicalTrials.gov Identifier:

NCT04131452

Other Study ID Numbers:

Bahceci Mehmet Asoglu

First Posted:

Oct 18, 2019

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Jan 18, 2020