InfertilityNCT04081870
IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective in Predicting Endometrial Implantation?
An observational study of Infertility, run by Benha University.
Trial summary
Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- 3D power doppler US
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2019
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: infertile women in need for ICSI due to male factor
Who may be able to join
- a
- age; 22-35 years,
- BMI; less than 35 kg/m2,
- Husband with oligo- or oligoasthenospermia.
Who cannot join
- \1-gross uterine and tubal pathology,
- 2-Development of OHSS,
- 3-poor responders,
- 4-failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and
- 5-Refusal to participate in the study at any step of the ICSI cycle.
About this study
Official title: IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective?
Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage.
Read the detailed description
All women underwent long agonist protocol for controlled ovarian hyperstimulation described by Chang et al. (14) The GnRH agonist was started in the previous mid-luteal phase (decapeptylR R 0.1mg, Triptorelin-Acetate, Ferring GmbH, Wittland 11, D-24109, and Kiel, Germany). After the confirmation of pituitary down regulation (serum LH less than 5 m IU/ml and serum E2 less than 50 pg /ml), the HMG ampoules were started by 225 IU/day (Gonapure 75 IU, IBSA Institute Biochimique SA, Switzerland). During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 (Choriomon 5000 IU, IBSA Institute Biochimique SA, Switzerland) was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Twelve days later to embryo transfer, serum pregnancy test was done and if positive (chemical pregnancy), the clinical pregnancy was confirmed by TVS for detection of gestational sacs and embryo cardiac activity. The ongoing pregnancy was detected by abdominal ultrasound at 12 weeks.
- Conditions
- Infertility
- Being tested
- 3D power doppler US
- Keywords
- doppler,endometrial,implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D power doppler USDiagnostic test
Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration.
| Study group | Role | What they receive |
|---|---|---|
| ICSI cases | All women underwent long agonist protocol for controlled ovarian hyperstimulation The GnRH agonist was started in the previous mid-luteal phase . After the confirmation of pituitary down regulation , the HMG ampoules were started by 225 IU/day . During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day . Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Receives: Diagnostic Test: 3D power doppler US |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemical pregnancy
positive pregnancy test
Measured: 14 day
the clinical pregnancy
was confirmed by TVS for detection of gestational sacs and embryo cardiac activity.
Measured: 28 day
The ongoing pregnancy
was detected by abdominal ultrasound at 12 weeks.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study startFeb 2014
- Primary completionApr 2019
- Study completionMay 2019
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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- khalid salama, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081870
- Sponsor's protocol ID
- khalid 6
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
PubMed 11756390
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective?
- ClinicalTrials.gov ID
- NCT04081870
- Acronym / sponsor ID
- khalid 6
- Conditions
- Infertility
- Keywords
- doppler,endometrial,implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 9 Sep 2019 (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.
Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage.
Detailed description
All women underwent long agonist protocol for controlled ovarian hyperstimulation described by Chang et al. (14) The GnRH agonist was started in the previous mid-luteal phase (decapeptylR R 0.1mg, Triptorelin-Acetate, Ferring GmbH, Wittland 11, D-24109, and Kiel, Germany). After the confirmation of pituitary down regulation (serum LH less than 5 m IU/ml and serum E2 less than 50 pg /ml), the HMG ampoules were started by 225 IU/day (Gonapure 75 IU, IBSA Institute Biochimique SA, Switzerland). During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 (Choriomon 5000 IU, IBSA Institute Biochimique SA, Switzerland) was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Twelve days later to embryo transfer, serum pregnancy test was done and if positive (chemical pregnancy), the clinical pregnancy was confirmed by TVS for detection of gestational sacs and embryo cardiac activity. The ongoing pregnancy was detected by abdominal ultrasound at 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICSI cases | – | Diagnostic Test: 3D power doppler USAll women underwent long agonist protocol for controlled ovarian hyperstimulation The GnRH agonist was started in the previous mid-luteal phase . After the confirmation of pituitary down regulation , the HMG ampoules were started by 225 IU/day . During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day . Five days following ovum pick up, the embryos were transferred at the blastocyst stage. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- infertile women in need for ICSI due to male factor
Key inclusion criteria (4 listed)
- a
- age; 22-35 years,
- BMI; less than 35 kg/m2,
- Husband with oligo- or oligoasthenospermia.
Key exclusion criteria (5 listed)
- \1-gross uterine and tubal pathology,
- 2-Development of OHSS,
- 3-poor responders,
- 4-failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and
- 5-Refusal to participate in the study at any step of the ICSI cycle.
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 |
|---|---|---|
| 3D power doppler USThree D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. | Diagnostic test | ICSI cases |
Primary outcome
chemical pregnancy
Time frame: 14 day
positive pregnancy test
the clinical pregnancy
Time frame: 28 day
was confirmed by TVS for detection of gestational sacs and embryo cardiac activity.
The ongoing pregnancy
Time frame: 3 months
was detected by abdominal ultrasound at 12 weeks.
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 11 Sep 2019.
- Results publication: PubMed 11756390Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
- Individual participant dataSharing planned: Undecided
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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.
khalid salama principal investigator
Benha University
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Benha University.
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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
chemical pregnancy (time frame: 14 day). The study lists 3 primary outcomes in all. 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 NCT04081870, 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 11 Sep 2019.