Fertility DisordersNCT03269916
Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel Disease
A study testing Anti Mueller hormone, Estrogen and Follicle-Stimulating Hormone in people with Fertility Disorders and Ovarian Reserve Function, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological… Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders, Ovarian Reserve Function, Pregnancy Outcomes
- What is being tested?
- Anti Mueller hormone, Estrogen and Follicle-Stimulating Hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Aug 2018
- 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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Inflammatory bowel disease
- 17-40 years old
- female
Who cannot join
- in pregnancy or lactation
- a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide
- reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor
- other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;
- malignant tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, 510000
xiang peng, MM, 18302076916, stefaniepx@163.com
About this study
Official title: Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel - a Cross-sectional Survey and Case Control Study
ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.This study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with IBD.
- Being tested
- Anti Mueller hormone, Estrogen, Follicle-Stimulating Hormone, Antral alveolar cell count
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Mueller hormoneOther
used to assess ovarian reserve parameters
EstrogenOther
used to assess ovarian reserve parameters
Follicle-Stimulating HormoneOther
used to assess ovarian reserve parameters
Antral alveolar cell countOther
used to assess ovarian reserve parameters
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Experimental | IBD patients, 17-40 years old, female Receives: Other: Anti Mueller hormone; Other: Estrogen; Other: Follicle-Stimulating Hormone; Other: Antral alveolar cell count |
| healthy control | Other | 17-40 years old , female, without any gynecological disease Receives: Other: Anti Mueller hormone; Other: Estrogen; Other: Follicle-Stimulating Hormone; Other: Antral alveolar cell count |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AMH of IBD patients is lower than that of healthy women
AMH is used to assess ovarian reserve function
Measured: 1 month
The E2 of IBD patients is lower than that of healthy women
E2 is used to assess ovarian reserve function
Measured: 1 month
The FSH of IBD patients is lower than that of healthy women
FSH is used to assess ovarian reserve function
Measured: 1 month
The AFC of IBD patients is lower than that of healthy women
AFC is used to assess ovarian reserve function
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 May 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pengxiang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Min Zhi, PHD, Study chair, The Sixth Affiliated Hospital of Zhongshan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269916
- Sponsor's protocol ID
- SixthSunYetSen
- Status last verified
- Aug 2017
- First submitted
- 13 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel - a Cross-sectional Survey and Case Control Study
- ClinicalTrials.gov ID
- NCT03269916
- Acronym / sponsor ID
- SixthSunYetSen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 1 Sep 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.
ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.This study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with IBD.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Experimental | Other: Anti Mueller hormone, Other: Estrogen, Other: Follicle-Stimulating Hormone, Other: Antral alveolar cell countIBD patients, 17-40 years old, female |
| healthy control | Other | Other: Anti Mueller hormone, Other: Estrogen, Other: Follicle-Stimulating Hormone, Other: Antral alveolar cell count17-40 years old , female, without any gynecological disease |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Inflammatory bowel disease
- 17-40 years old
- female
Key exclusion criteria (5 listed)
- in pregnancy or lactation
- a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide
- reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor
- other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;
- malignant tumor
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 |
|---|---|---|
| Anti Mueller hormoneused to assess ovarian reserve parameters | Other | IBD patients, healthy control |
| Estrogenused to assess ovarian reserve parameters | Other | IBD patients, healthy control |
| Follicle-Stimulating Hormoneused to assess ovarian reserve parameters | Other | IBD patients, healthy control |
| Antral alveolar cell countused to assess ovarian reserve parameters | Other | IBD patients, healthy control |
Primary outcome
The AMH of IBD patients is lower than that of healthy women
Time frame: 1 month
AMH is used to assess ovarian reserve function
The E2 of IBD patients is lower than that of healthy women
Time frame: 1 month
E2 is used to assess ovarian reserve function
The FSH of IBD patients is lower than that of healthy women
Time frame: 1 month
FSH is used to assess ovarian reserve function
The AFC of IBD patients is lower than that of healthy women
Time frame: 1 month
AFC is used to assess ovarian reserve function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- 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.
Min Zhi, PHD study chair
The Sixth Affiliated Hospital of Zhongshan 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 Anti Mueller hormone, Estrogen and Follicle-Stimulating Hormone in people with Fertility Disorders and Ovarian Reserve Function, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 1 Sep 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 China. 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 xiang peng, MM (18302076916, stefaniepx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AMH of IBD patients is lower than that of healthy women (time frame: 1 month). The study lists 4 primary outcomes in all. 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 1 Sep 2017.