Infertility, FemaleNCT03473028
Transvaginal Ultrasonography Guided Embryo Transfer
A study testing transabdominal ultrasound guided embryo transfer and transvaginal ultrasound guided embryo transfer in people with Infertility, Female, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- transabdominal ultrasound guided embryo transfer and transvaginal ultrasound guided embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study
to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- transabdominal ultrasound guided embryo transfer, transvaginal ultrasound guided embryo transfer
- Keywords
- obesity, embryo transfer, invitro fertilization
- Medical subject headings
- Infertility, Female, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transabdominal ultrasound guided embryo transferProcedure or surgery
400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer
transvaginal ultrasound guided embryo transferProcedure or surgery
400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| transabdominal ultrasound | Active comparator | 400 obese female undergo transabdominal ultrasound guided embryo transfer Receives: Procedure: transabdominal ultrasound guided embryo transfer |
| transvaginal group | Active comparator | 400 obese female undergo transvaginal ultrasound guided embryo transfer Receives: Procedure: transvaginal ultrasound guided embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate'
the presence of at least one intrauterine gestational sac with viable fetus.
Measured: 4 weeks following embryo transfer
Secondary outcomes (1)
live birth rate
delivery of a living baby
Measured: immediately following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Apr 2018
- Primary completion18 Feb 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473028
- Sponsor's protocol ID
- 2019
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34584462
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03473028
- Acronym / sponsor ID
- 2019
- Conditions
- Infertility, Female
- Keywords
- obesity, embryo transfer, invitro fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| transabdominal ultrasound | Active comparator | Procedure: transabdominal ultrasound guided embryo transfer400 obese female undergo transabdominal ultrasound guided embryo transfer |
| transvaginal group | Active comparator | Procedure: transvaginal ultrasound guided embryo transfer400 obese female undergo transvaginal ultrasound guided embryo transfer |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transabdominal ultrasound guided embryo transfer400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer | Procedure or surgery | transabdominal ultrasound |
| transvaginal ultrasound guided embryo transfer400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer | Procedure or surgery | transvaginal group |
Primary outcome
clinical pregnancy rate'
Time frame: 4 weeks following embryo transfer
the presence of at least one intrauterine gestational sac with viable fetus.
1 secondary outcome
live birth rate
Time frame: immediately following delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 34584462Mohamed 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.
Related trials for Infertility, Female
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transabdominal ultrasound guided embryo transfer and transvaginal ultrasound guided embryo transfer in people with Infertility, Female, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate' (time frame: 4 weeks following embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.