NCT04131452

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

October 16, 2019

Last Update Submit

January 14, 2020

Conditions

Infertility, FemaleAnxiety StateDepressionQuality of LifeSexual Function and Fertility Disorders

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

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

    At around 7 weeks of gestation

Secondary Outcomes (2)

  • Implantation rate

    At around 6 weeks of gestation

  • Live birth rate

    24 completed weeks of gestation

Study Arms (2)

Fresh embryo transfers

those undergoing fresh embryo transfer

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

Frozen embryo transfers

those undergoing frozen embriyo transfer

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

Interventions

Filling out the forms including IDAS-II, BAI, SF-36 and FSFIOTHER

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).

Fresh embryo transfersFrozen embryo transfers

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceci Health Group

Istanbul, Sisli, 34394, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30211664RESULT

  • 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.

    PMID: 29622404RESULT

MeSH Terms

Conditions

Infertility, FemaleAnxiety DisordersDepression

Interventions

Bays

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Oceans and SeasGeological PhenomenaPhysical Phenomena

Study Officials

  • Mehmet Resit Asoglu, Ass, prof

    Bahceci Health Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Resit Asoglu, Ass. Prof

CONTACT

+90 530 923 83 16mresitasoglu@hotmail.com

Cem Celik, Prof

CONTACT

+90 532 420 5365cemcel@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

January 20, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)