Invitro FertilizationNCT02383394
Factors Associated With Pregnancy Loss in IVF Women
An observational study of Invitro Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women only
- Conditions the study is for
- Invitro Fertilization
- What is being tested?
- follow up antenatal care
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Aug 2017
- 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 21 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)
Who may be able to join
- Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)
Who cannot join
- abnormal uterine cavity induced abortion for medical problem
Trial locations and contacts
1 site in 1 country.
Adel Nada, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Maged
Cairo, 12151
Ahmed Maged, MD
Ahmed Shaker, MD
About this study
Official title: Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization
Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.
Read the detailed description
Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.
Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.
- Conditions
- Invitro Fertilization
- Being tested
- follow up antenatal care
- Keywords
- second trimesteric pregnancy loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up antenatal careOther
ultrasound follow up of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| aborted women | women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring Receives: Other: follow up antenatal care | |
| continued women | women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring Receives: Other: follow up antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
second trimester abortion
Measured: between 12 1/7 and 23 6/7 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invitro FertilizationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383394
- Sponsor's protocol ID
- 131
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT02383394
- Acronym / sponsor ID
- 131
- Conditions
- Invitro Fertilization
- Keywords
- second trimesteric pregnancy loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 Mar 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.
Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.
Detailed description
Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.
Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aborted women | – | Other: follow up antenatal carewomen who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring |
| continued women | – | Other: follow up antenatal carewomen who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)
Key inclusion criteria (1 listed)
- Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)
Key exclusion criteria (1 listed)
- abnormal uterine cavity induced abortion for medical problem
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 |
|---|---|---|
| follow up antenatal careultrasound follow up of pregnancy | Other | aborted women, continued women |
Primary outcome
second trimester abortion
Time frame: between 12 1/7 and 23 6/7 weeks of gestation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Adel Nada, MD contact
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
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 Invitro Fertilization, run by Cairo University 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: status not confirmed, as of the sponsor's last update on 5 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
second trimester abortion (time frame: between 12 1/7 and 23 6/7 weeks of gestation)). 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 5 Apr 2017.