InfertilityNCT02351193
a Predictive Scheme for Poor Responders in IVF Cycles
An observational study of Infertility, run by Dina Mohamed Refaat Dakhly at 1 site in Egypt.
Trial summary
While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- transvaginal Ultrasound
- How many people
- 928 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Dec 2013
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Poor responder females
Who may be able to join
- normal body mass index (BMI)
- AMH from 0.5-1.1 ng/ml.
- previous history of ≤3 oocytes retrieved using conventional long stimulation protocol
Who cannot join
- Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis
- severe cases of male factor as azospermia
- females who were unable or not willing to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Predictive Scheme to Assess the Outcome of IVF/ICSI Cycles in Poor Responders. an Observational Study in Egypt
While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.
- Conditions
- Infertility
- Being tested
- transvaginal Ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal UltrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| Group I | poor responder females with age less than 35 Receives: Other: transvaginal Ultrasound | |
| Group II | poor responder females with age more than 35 Receives: Other: transvaginal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MII oocytes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Mohamed Refaat Dakhly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351193
- Sponsor's protocol ID
- 26012015
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Scheme to Assess the Outcome of IVF/ICSI Cycles in Poor Responders. an Observational Study in Egypt
- ClinicalTrials.gov ID
- NCT02351193
- Acronym / sponsor ID
- 26012015
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Dina Mohamed Refaat DakhlyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jan 2015 (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.
While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: transvaginal Ultrasoundpoor responder females with age less than 35 |
| Group II | – | Other: transvaginal Ultrasoundpoor responder females with age more than 35 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Poor responder females
Key inclusion criteria (3 listed)
- normal body mass index (BMI)
- AMH from 0.5-1.1 ng/ml.
- previous history of ≤3 oocytes retrieved using conventional long stimulation protocol
Key exclusion criteria (3 listed)
- Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis
- severe cases of male factor as azospermia
- females who were unable or not willing to participate in the study were excluded from the study.
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 |
|---|---|---|
| transvaginal Ultrasound | Other | Group I, Group II |
Primary outcome
Number of MII oocytes
Time frame: 2 years
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 2 Feb 2015.
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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.
Dina MR Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Dina Mohamed Refaat Dakhly 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 3 inclusion and 3 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 2 Feb 2015. 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?
Number of MII oocytes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2015.