Polycystic Ovary Syndrome IVFNCT03120286
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS
An observational study of Polycystic Ovary Syndrome IVF, run by Assiut University.
Trial summary
The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight. Design: Retrospective cohort study. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome IVF
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Sep 2016
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: This is a retrospective study to evaluate the impact of obesity on ivf outcomes.
Who may be able to join
- All women within the age limit
Who cannot join
None listed.
About this study
Official title: OVERWEIGHT AND OBESITY ADVERSELY AFFECT IN VITRO FERTILIZATION (IVF) OUTCOMES IN WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS)
The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight.
Design: Retrospective cohort study.
- Conditions
- Polycystic Ovary Syndrome IVF
- Keywords
- OBESITY, In Vitro Fertilization (IVF), Polycystic ovary syndrome (PCOS)
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overweight and obesity | Women with BMI >25 | |
| Normal weight group | Women with BMI =18-24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Number of live births divided by the number of aspiration cycle
Measured: On the date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome IVFStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120286
- Sponsor's protocol ID
- BMI
- Status last verified
- May 2017
- First submitted
- 15 Apr 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OVERWEIGHT AND OBESITY ADVERSELY AFFECT IN VITRO FERTILIZATION (IVF) OUTCOMES IN WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS)
- ClinicalTrials.gov ID
- NCT03120286
- Acronym / sponsor ID
- BMI
- Conditions
- Polycystic Ovary Syndrome IVF
- Keywords
- OBESITY, In Vitro Fertilization (IVF), Polycystic ovary syndrome (PCOS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Apr 2017 (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.
The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight.
Design: Retrospective cohort study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight and obesity | – | –Women with BMI >25 |
| Normal weight group | – | –Women with BMI =18-24 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a retrospective study to evaluate the impact of obesity on ivf outcomes.
Key inclusion criteria (1 listed)
- All women within the age limit
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate
Time frame: On the date of delivery
Number of live births divided by the number of aspiration cycle
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 May 2017.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome IVF
Recruiting
Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS
Polycystic Ovary Syndrome (PCOS), Female Infertility
Recruiting
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Polycystic Ovary Syndrome (PCOS), In Vitro Maturation of Oocytes
RecruitingObservational study
Clinical Application of Serum Anti-Müllerian Hormone (AMH) Measurements
Anti-Müllerian Hormone, Polycystic Ovarian Syndrome
Recruiting
In Vitro Maturation of Human Eggs
Healthy, PCOS
Recruiting
IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome IVF, run by Assiut 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 1 inclusion and 0 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 May 2017. 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?
Live birth rate (time frame: On the date of delivery). 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 11 May 2017.