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

January 14, 2020 updated by: Mehmet Resit Asoglu, Bahceci Health Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Sisli
      • Istanbul, Sisli, Turkey, 34394
        • Bahceci Health Group
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Study population will consist of women undergoing fresh or frozen embryo transfer after assisted reproductive treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At around 7 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: At around 6 weeks of gestation
Implantation is defined as presence of intrauterine gestational sac at around 6 weeks of gestation.
At around 6 weeks of gestation
Live birth rate
Time Frame: 24 completed weeks of gestation
Live birth is defined as at least a live birth after 24 completed weeks of gestation.
24 completed weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahceci Health Group

Collaborators

Uskudar University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bahceci Mehmet Asoglu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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