Fertility Preservation SurgeryNCT03882190
The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
A study testing GnRHa in people with Fertility Preservation Surgery and Ovarian Malignancy, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery Read more about this study
- Who is it for?
- Ages 1 year to 90 years, women only
- Conditions the study is for
- Fertility Preservation Surgery, Ovarian Malignancy
- What is being tested?
- GnRHa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2021
- 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 1 year to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteer to participate in the study with informed consent;
- Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.
Who cannot join
- Pregnancy, lactation and postmenopause;
- Suspected or identified as other tumors of genital tract;
- History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- Other diseases or heavy injuries that will interfere with the results;
- Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Trial locations and contacts
No sites are listed yet.
About this study
The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery
Read the detailed description
20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.
- Conditions
- Fertility Preservation Surgery, Ovarian Malignancy
- Being tested
- GnRHa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRHaDrug
patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation
| Study group | Role | What they receive |
|---|---|---|
| group 1 | No intervention | Not described |
| group 2 | Experimental | Not described Receives: Drug: GnRHa |
What is being measured
The primary outcome is the main question the study is designed to answer.
the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L)
by monitoring six above-mentioned hormones preoperatively and postoperatively, the ovarian function is evaluated
Measured: 1 year during the perioperative period
the volume of ovary(cm*cm*cm)
by monitoring the change of ovarian form and volume, we evaluate the physical ovarian transformation
Measured: 1 year during the perioperative period
the ovulating period
by comparing the ovulating period perioperatively and postoperatively between two groups, we assess the GnRHa effect on the reproductive function
Measured: 1 year during the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility Preservation SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882190
- Sponsor's protocol ID
- SAHoWMU-CR2019-07-101
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
- ClinicalTrials.gov ID
- NCT03882190
- Acronym / sponsor ID
- SAHoWMU-CR2019-07-101
- Conditions
- Fertility Preservation Surgery, Ovarian Malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 20 Mar 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.
The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery
Detailed description
20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | No intervention | – |
| group 2 | Experimental | Drug: GnRHa |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteer to participate in the study with informed consent;
- Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.
Key exclusion criteria (5 listed)
- Pregnancy, lactation and postmenopause;
- Suspected or identified as other tumors of genital tract;
- History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- Other diseases or heavy injuries that will interfere with the results;
- Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
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 |
|---|---|---|
| GnRHapatients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation | Drug | group 2 |
Primary outcome
the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L)
Time frame: 1 year during the perioperative period
by monitoring six above-mentioned hormones preoperatively and postoperatively, the ovarian function is evaluated
the volume of ovary(cm*cm*cm)
Time frame: 1 year during the perioperative period
by monitoring the change of ovarian form and volume, we evaluate the physical ovarian transformation
the ovulating period
Time frame: 1 year during the perioperative period
by comparing the ovulating period perioperatively and postoperatively between two groups, we assess the GnRHa effect on the reproductive function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing GnRHa in people with Fertility Preservation Surgery and Ovarian Malignancy, run by Second Affiliated Hospital of Wenzhou Medical 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 2 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 20 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu ZHAO, Ph.D (13777760306, zhaoyu196035@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L) (time frame: 1 year during the perioperative period). 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?
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 20 Mar 2019.