NCT03473028

Brief Summary

to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

March 15, 2018

Last Update Submit

April 6, 2021

Conditions

Keywords

obesityembryo transferinvitro fertilization

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate'

    the presence of at least one intrauterine gestational sac with viable fetus.

    4 weeks following embryo transfer

Secondary Outcomes (1)

  • live birth rate

    immediately following delivery

Study Arms (2)

transabdominal ultrasound

ACTIVE COMPARATOR

400 obese female undergo transabdominal ultrasound guided embryo transfer

Procedure: transabdominal ultrasound guided embryo transfer

transvaginal group

ACTIVE COMPARATOR

400 obese female undergo transvaginal ultrasound guided embryo transfer

Procedure: transvaginal ultrasound guided embryo transfer

Interventions

400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer

transabdominal ultrasound

400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer

transvaginal group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.

You may not qualify if:

  • severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

Related Publications (1)

  • Mohamed Hassan S, Ramadan W, Elsharkawy M, Ali Bayoumi Y. The Role of Transvaginal Ultrasound Guided Embryo Transfer to Improve Pregnancy Rate in Obese Patients Undergoing Intracytoplasmic Sperm Injection. Int J Womens Health. 2021 Sep 21;13:861-867. doi: 10.2147/IJWH.S325557. eCollection 2021.

MeSH Terms

Conditions

Infertility, FemaleObesity

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 21, 2018

Study Start

April 1, 2018

Primary Completion

February 18, 2021

Study Completion

March 4, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations