InfertilityETNCT01810601
Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates
A study testing GnRh, HMG, HCG, Progesterone in people with Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- GnRh, HMG, HCG, Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2009to Aug 2011
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (20-39)
- Male factor infertility
- Ovarian factor infertility
- Unexplained infertility
Who cannot join
- Tubal factor infertility
- Endometriosis
- FSH > 16 iu/l on cycle day 3
- Less than 2 embryos grade A
- Difficult embryo transfer
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique
Read the detailed description
A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique
- Conditions
- Infertility
- Being tested
- GnRh, HMG, HCG, Progesterone
- Keywords
- Embryo transfer, transabdominal ultrasound, IVF, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRh, HMG, HCG, ProgesteroneDrug
GnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided embryo transfer | Experimental | GnRh, HMG, HCG, Progesterone 45 patients had ultrasound guided embryo transfer during ICSI Receives: Drug: GnRh, HMG, HCG, Progesterone |
| clinical touch technique | Placebo comparator | GnRh, HMG, HCG, Progesterone 45 patients had embryo transfer using clinical touch technique during ICSI Receives: Drug: GnRh, HMG, HCG, Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess clinical pregnancy rates after using ultrasound guided embryo transfer
Measured: After December, 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
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 InfertilityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Rabei, Ain Shams Maternity Hospital
- Investigators
- Ahmed R Ammar, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810601
- Sponsor's protocol ID
- noharabei-1
- Acronym
- ET
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coroleu B, Barri PN, Carreras O, Belil I, Buxaderas R, Veiga A, Balasch J. Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study. Hum Reprod. 2006 Jul;21(7):1809-15. doi: 10.1093/humrep/del045. Epub 2006 Mar 23.
PubMed 16556674
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates
- ClinicalTrials.gov ID
- NCT01810601
- Acronym / sponsor ID
- ET / noharabei-1
- Conditions
- Infertility
- Keywords
- Embryo transfer, transabdominal ultrasound, IVF, ICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Mar 2013 (estimated)
- 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 assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique
Detailed description
A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided embryo transfer | Experimental | Drug: GnRh, HMG, HCG, ProgesteroneGnRh, HMG, HCG, Progesterone 45 patients had ultrasound guided embryo transfer during ICSI |
| clinical touch technique | Placebo comparator | Drug: GnRh, HMG, HCG, ProgesteroneGnRh, HMG, HCG, Progesterone 45 patients had embryo transfer using clinical touch technique during ICSI |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age (20-39)
- Male factor infertility
- Ovarian factor infertility
- Unexplained infertility
Key exclusion criteria (5 listed)
- Tubal factor infertility
- Endometriosis
- FSH > 16 iu/l on cycle day 3
- Less than 2 embryos grade A
- Difficult embryo transfer
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 |
|---|---|---|
| GnRh, HMG, HCG, ProgesteroneGnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day) | Drug | Ultrasound guided embryo transfer, clinical touch technique |
Primary outcome
To assess clinical pregnancy rates after using ultrasound guided embryo transfer
Time frame: After December, 2012
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 26 Mar 2013.
- Background: PubMed 16556674Coroleu B, Barri PN, Carreras O, Belil I, Buxaderas R, Veiga A, Balasch J. Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study. Hum Reprod. 2006 Jul;21(7):1809-15. doi: 10.1093/humrep/del045. Epub 2006 Mar 23.
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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.
Ahmed R Ammar, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRh, HMG, HCG, Progesterone in people with Infertility, run by Ain Shams Maternity 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 4 inclusion and 5 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 26 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
To assess clinical pregnancy rates after using ultrasound guided embryo transfer (time frame: After December, 2012). 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 NCT01810601, 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 26 Mar 2013.