Tubal-preserving Treatment of Tubal Ectopic PregnancyTSOPFPATEPTNCT05498558
The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment
An observational study of Tubal-preserving Treatment of Tubal Ectopic Pregnancy and Tubal Pregnancy, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Tubal-preserving Treatment of Tubal Ectopic Pregnancy, Tubal Pregnancy, Pregnancy Preparation
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 18 to 41 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200120
About this study
Official title: 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.
Read the 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.
- Conditions
- Tubal-preserving Treatment of Tubal Ectopic Pregnancy, Tubal Pregnancy, Pregnancy Preparation
- Being tested
- No intervention.
- Medical subject headings
- Pregnancy, Tubal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tubal pregnancy within12 months in both groups of patients.
Tubal ectopic pregnancy refers to the implantation of embryo in the fallopian tubes.
Measured: 2023.10
Secondary outcomes (1)
Rates of pregnancy and miscarriage within 12 months in both groups of patients.
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.
Measured: 2023.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tubal-preserving Treatment of Tubal Ectopic PregnancyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 7th People's Hospital, Shanghai Zhoupu Hospital, Shanghai Pudong Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498558
- Sponsor's protocol ID
- ShanghaiFMIH2022-LSD
- Acronym
- TSOPFPATEPT
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plan is undecided now.
Publications
Mol F, van Mello NM, Strandell A, Strandell K, Jurkovic D, Ross J, Barnhart KT, Yalcinkaya TM, Verhoeve HR, Graziosi GCM, Koks CAM, Klinte I, Hogstrom L, Janssen ICAH, Kragt H, Hoek A, Trimbos-Kemper TCM, Broekmans FJM, Willemsen WNP, Ankum WM, Mol BW, van Wely M, van der Veen F, Hajenius PJ; European Surgery in Ectopic Pregnancy (ESEP) study group. Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial. Lancet. 2014 Apr 26;383(9927):1483-1489. doi: 10.1016/S0140-6736(14)60123-9. Epub 2014 Feb 3.
PubMed 24499812
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment In Pudong New Area
- ClinicalTrials.gov ID
- NCT05498558
- Acronym / sponsor ID
- TSOPFPATEPT / ShanghaiFMIH2022-LSD
- Conditions
- Tubal-preserving Treatment of Tubal Ectopic Pregnancy, Tubal Pregnancy, Pregnancy Preparation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Collaborators
- Shanghai 7th People's Hospital, Shanghai Zhoupu Hospital, Shanghai Pudong Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Aug 2022 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovulation occurs on the healthy side | – | Other: No intervention.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. |
| Ovulation occurs on the either side | – | Other: No intervention.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. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| No intervention.No intervention. | Other | Ovulation occurs on the either side, Ovulation occurs on the healthy side |
Primary outcome
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.
1 secondary outcome
Rates of pregnancy and miscarriage within 12 months in both groups of patients.
Time frame: 2023.10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Results publication: PubMed 24499812Mol F, van Mello NM, Strandell A, Strandell K, Jurkovic D, Ross J, Barnhart KT, Yalcinkaya TM, Verhoeve HR, Graziosi GCM, Koks CAM, Klinte I, Hogstrom L, Janssen ICAH, Kragt H, Hoek A, Trimbos-Kemper TCM, Broekmans FJM, Willemsen WNP, Ankum WM, Mol BW, van Wely M, van der Veen F, Hajenius PJ; European Surgery in Ectopic Pregnancy (ESEP) study group. Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial. Lancet. 2014 Apr 26;383(9927):1483-1489. doi: 10.1016/S0140-6736(14)60123-9. Epub 2014 Feb 3.
- Individual participant dataSharing planned: Undecided. IPD sharing plan is undecided now.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tubal-preserving Treatment of Tubal Ectopic Pregnancy and Tubal Pregnancy, run by Shanghai First Maternity and Infant Hospital 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 13 inclusion and 13 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 12 Aug 2022. 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?
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?
Rate of tubal pregnancy within12 months in both groups of patients. (time frame: 2023.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05498558, which also lists 1 linked publication.
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 12 Aug 2022.