An observational study in Tubal-preserving Treatment of Tubal Ectopic Pregnancy, Tubal Pregnancy and Pregnancy Preparation, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Shanghai First Maternity and Infant Hospital · Observational
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.
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.
Shanghai First Maternity and Infant Hospital is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: No intervention.
No intervention.
Rate of tubal pregnancy within12 months in both groups of patients.
Tubal ectopic pregnancy refers to the implantation of embryo in the fallopian tubes.
Time frame: 2023.10
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.
Time frame: 2023.10
Plan to share: Undecided — IPD sharing plan is undecided now.
Start is estimated for Jan 2023; primary completion for Oct 2023, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Pregnancy, Tubal
Shanghai First Maternity and Infant Hospital