Transvaginal Ultrasonography Guided Embryo Transfer

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03473028
• Collaborator: (none)
• Enrollment: 800
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.1
• Patients Per Site Per Month: 22.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Procedure: transabdominal ultrasound guided embryo transfer; Procedure: transvaginal ultrasound guided embryo transfer	N/A

Detailed Description

The 800 participants with body mass index more than 30kg/m2 were randomly allocated to two groups of equal size using an automated web-based randomization system. The first group 400 patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient undergoing transvaginal-guided embryo transfer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Feb 18, 2021
• Actual Study Completion Date: Mar 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: transabdominal ultrasound 400 obese female undergo transabdominal ultrasound guided embryo transfer	Procedure: transabdominal ultrasound guided embryo transfer; 400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer
Active Comparator: transvaginal group 400 obese female undergo transvaginal ultrasound guided embryo transfer	Procedure: transvaginal ultrasound guided embryo transfer; 400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer

Outcome Measures

Primary Outcome Measures

1. clinical pregnancy rate' [4 weeks following embryo transfer]

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

Secondary Outcome Measures

1. live birth rate [immediately following delivery]

   delivery of a living baby

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr El Ainiy Hospital	Cairo		Egypt	11562

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT03473028
• Other Study ID Numbers: 2019
• First Posted: Mar 21, 2018
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by sarah mohamed hassan, lecturer of obstetrics and gynecology, Kasr El Aini Hospital: obesity; embryo transfer; invitro fertilization
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of Apr 8, 2021