Infertility Associated With EndometriosisNCT02779387
Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy
A study testing Goserelin Acetate in people with Infertility Associated With Endometriosis, run by Peking University People's Hospital.
Trial summary
This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility Associated With Endometriosis
- What is being tested?
- Goserelin Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,184 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile patients
- Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996
- BMI:19-28 kg/㎡
- Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml）
Who cannot join
- Male factor causes infertility
- hydrosalpinx or salpingemphraxis
- Uterine malformation
- Uterine cavity lesion
- Contra-indications for GnRH-a
- not willing to participate
About this study
Official title: Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.
- Being tested
- Goserelin Acetate
- Keywords
- GnRH-a, endometriosis, efficiency
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goserelin AcetateDrug
| Study group | Role | What they receive |
|---|---|---|
| GnRH-a | Experimental | patients treated with GnRH-a after surgery and Outpatient guidance
. Receives: Drug: Goserelin Acetate |
| non GnRH-a | No intervention | patients treated with outpatient guidance only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative pregnancy rate
Cumulative pregnancy rate of 18 month after surgery
Measured: 18 month after surgery
Time interval between surgery and natural pregnancy
Time interval between surgery and natural pregnancy
Measured: 18 month after surgery
miscarriage rate
miscarriage rate of patients who get natural pregnancy
Measured: 18 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Associated With EndometriosisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 1,184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu xiaoming, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779387
- Sponsor's protocol ID
- PKU01001
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Willing to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
- ClinicalTrials.gov ID
- NCT02779387
- Acronym / sponsor ID
- PKU01001
- Keywords
- GnRH-a, endometriosis, efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,184 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 20 May 2016 (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.
This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH-a | Experimental | Drug: Goserelin Acetatepatients treated with GnRH-a after surgery and Outpatient guidance . |
| non GnRH-a | No intervention | –patients treated with outpatient guidance only. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile patients
- Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996
- BMI:19-28 kg/㎡
- Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml）
Key exclusion criteria (6 listed)
- Male factor causes infertility
- hydrosalpinx or salpingemphraxis
- Uterine malformation
- Uterine cavity lesion
- Contra-indications for GnRH-a
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 |
|---|---|---|
| Goserelin Acetate | Drug | GnRH-a |
Primary outcome
Cumulative pregnancy rate
Time frame: 18 month after surgery
Cumulative pregnancy rate of 18 month after surgery
Time interval between surgery and natural pregnancy
Time frame: 18 month after surgery
Time interval between surgery and natural pregnancy
miscarriage rate
Time frame: 18 month after surgery
miscarriage rate of patients who get natural pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: Yes. Willing to share IPD
Related trials for Infertility Associated With Endometriosis
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Endometriosis Pelvic, Endometriosis Ovaries
Active, not recruiting
IVF Versus Surgery for Endometriosis Related Infertility
Endometriosis
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?
A study testing Goserelin Acetate in people with Infertility Associated With Endometriosis, run by Peking University People's Hospital.
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 4 inclusion and 6 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 May 2016. 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?
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?
Cumulative pregnancy rate (time frame: 18 month after surgery). 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 May 2016.