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Clinical Trials/NCT04131452
NCT04131452UnknownNot Applicable

Do Women's Quality of Life, Sexual Life and Psychological State Differ Between Patients Undergoing Fresh and Frozen Embryo Transfers: a Prospective Study

Bahceci Health Group1 site in 1 country232 target enrollmentStarted: January 20, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
232
Locations
1
Primary Endpoint
Clinical pregnancy rate

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 39 Years (Adult)
Sex
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)

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: At around 7 weeks of gestation

Clinical pregnancy is defined as the presence of intrauterine fetal heartbeat at around 7 weeks of gestation.

Secondary Outcomes

  • Implantation rate(At around 6 weeks of gestation)
  • Live birth rate(24 completed weeks of gestation)

Investigators

Sponsor
Bahceci Health Group
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Resit Asoglu

Associate professor

Bahceci Health Group

Study Sites (1)

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