- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05498558
The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment (TSOPFPATEPT)
August 10, 2022 updated by: Shanghai First Maternity and Infant Hospital
The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment In Pudong New Area
The incidence of re-ectopic pregnancy in patients with tubal ectopic pregnancy increases significantly, which may be related to the condition of the fallopian tubes, such as tubal inflammation, tubal obstruction and other high-risk factors that may lead to tubal ectopic pregnancy; it is also associated with the treatment of the previous tubal ectopic pregnancy.
Compared with salpingectomy, the treatment of preserving the fallopian tubes increased the incidence of re-ectopic pregnancy while increasing the pregnancy rate of the patient.
For tubal-preserving patients, the most common option currently used is to recommend that monitoring ovulation during each menstrual cycle if they choose to conceive naturally rather than IVF.
If ovulation occures on the healthy side of the ovary, it may be considered to try to conceive; Otherwise, contraception is recommended.
However, there are uncertainties about this option.
Based on this, we intend to conduct a multicenter clinical trial to verify the effectiveness of the ovulation preparation regimen on the healthy side of ovary.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Tubal ectopic pregnancy is a disease that seriously affects women's physical and mental health and reproductive health, not only can there be some short-term complications such as rupture of tubal pregnancy and massive bleeding in the abdominal cavity, but also can lead to a decrease in female fertility, and the incidence of subsequent ectopic pregnancy has increased significantly.
In recent years, with the development of diagnosis and treatment methods, the proportion of serious clinical events such as rupture of tubal pregnancy and massive hemorrhage in patients has decreased significantly.
However, there is little research on the long-term damage of tubal pregnancy to women's fertility, especially how to avoid the occurrence of re-ectopic pregnancy, and there is no definitive and effective program.The incidence of re-ectopic pregnancy in patients with tubal ectopic pregnancy increases significantly, which may be related to the condition of the fallopian tubes, such as tubal inflammation, tubal obstruction and other high-risk factors that may lead to tubal ectopic pregnancy; it is also associated with the treatment of the previous tubal ectopic pregnancy.
Compared with salpingectomy, the treatment of preserving the fallopian tubes increased the incidence of re-ectopic pregnancy while increasing the pregnancy rate of the patient.It is reported that the incidence of re-ectopic pregnancy in patients who choose salpingotomy is significantly higher than salpingectomy.Patients receiving conservative treatment and expectant treatment with methotrexate have a similar incidence of re-ectopic pregnancy as in patients receving salpingotomy.For tubal-preserving patients, the most common option currently used is to recommend that monitoring ovulation during each menstrual cycle if they choose to conceive naturally rather than IVF.
If ovulation occures on the healthy side of the ovary, it may be considered to try to conceive; Otherwise, contraception is recommended.
However, there are uncertainties about this option.
Based on this, we intend to conduct a multicenter clinical trial to verify the effectiveness of the ovulation preparation program on the healthy side of ovary.We plan to randomly divide patients who meet the inclusion criteria into two groups:preparation for pregnancy in each ovulatory cycle and in healthy ovulatory cycle.
Monitor the development of the patient's follicles each cycle, follow the patient to pregnancy, and analyze the patient's ovulation rate of healthy ovary, pregnancy rate, ectopic pregnancy rate and the time required from preparation to be pregnant, so as to determine whether the healthy side ovulation preparation program can improve the patient's normal pregnancy rate and reduce the ectopic pregnancy rate.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200120
- Shanghai first maternity and infant hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients with fertility needs who received tubal-preserving treatment during prior tubal ectopic pregnant in Shanghai First Maternity and Infant Hospital, Shanghai Zhoupu Hospital, Shanghai Seventh People's Hospital.
Description
Inclusion Criteria:
- After tubal pregnancy treatment (including expectant therapy, medication, salpingotomy), the blood hCG value returns to normal;
- The patient has fertility requirements;
- The age of the patient is between 18-41 years old;
- Regular menstruation;
- There is no abnormality in the husband's semen examination;
- No history of sex hormone drugs in the 3 months prior to the examination;
- No underlying diseases such as heart, liver, kidneys and brain;
- No history of tuberculosis;
- Normal blood routine examination (WBC≥ 4*109/L, HB≥100g/L, PLT≥100*109/L);
- Normal liver and kidney function tests;
- Normal thyroid function;
- The patient can withstand and receive follicle monitoring during pregnancy;
- Negative for pregnancy test before treatment.
Exclusion Criteria:
- Cervical pregnancy, cesarean scar pregnancy, cornual pregnancy, interstitial pregnancy;
- The age of the patient < 18 years or > 41 years;
- Irregular menstruation or abnormal results of sex hormone tests during follow-up;
- Abnormal results of the man's semen examination during the follow-up period;
- The patient has a tendency to bleed easily;
- History of myometriosis and endometriosis;
- Abnormal blood routine examination or liver and kidney function;
- History of cardiovascular diseases, including severe hypertension, severe arrhythmias, history of myocardial infarction;
- History of hepatitis B or C infection and patient has a detectable viral load;
- Patients with active tuberculosis;
- History of malignant tumors;
- Unable to regularly monitor the follicles during pregnancy;
- Unconditional long-term follow-up;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ovulation occurs on the healthy side
In tubal-presering patient who received treatment of tubal ectopic pregnancy,only when ovulation occurs on the healthy side of ovary,it may be considered to try to conceive; otherwise, contraception is recommended.
|
No intervention.
|
Ovulation occurs on the either side
In tubal-presering patient who received treatment of tubal ectopic pregnancy,ovulation occurs on the either side of ovary,it may be considered to try to conceive.
|
No intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of tubal pregnancy within12 months in both groups of patients.
Time Frame: 2023.10
|
Tubal ectopic pregnancy refers to the implantation of embryo in the fallopian tubes.
|
2023.10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of pregnancy and miscarriage within 12 months in both groups of patients.
Time Frame: 2023.10
|
Clinical pregnancy is defined as ultrasound suggesting a gestational sac, with or without fetal heartbeat; miscarriage is defined as ultrasound suggesting that the fetus is inanimate or that the fetus has miscarried spontaneously.
|
2023.10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
October 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
August 10, 2022
First Submitted That Met QC Criteria
August 10, 2022
First Posted (Actual)
August 12, 2022
Study Record Updates
Last Update Posted (Actual)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 10, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShanghaiFMIH2022-LSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
IPD sharing plan is undecided now.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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