Didroxyprogesterone Promotes Natural Pregnancy in Infertile Patients With Endometriosis

Summary

Endometriosis (EM) is an important cause of infertility in women of childbearing age. Laparoscopic surgery is the treatment of EM Related infertility is an important method. However, excluding other infertility factors, the natural pregnancy rate of EM patients one year after operation is still significantly lower than that of normal couples. At the same time, the high recurrence rate of EM often requires drugs to inhibit ovulation after operation, which forms a paradox with the demand for fertility. One year after operation is the "golden period" of natural pregnancy. Whether to treat the recurrence of EM without affecting or even promoting fertility is a key problem to be solved in clinic. Didroxyprogesterone is the closest natural progesterone. It is widely used in luteal support and treatment of threatened abortion. It does not affect ovulation and is harmless to embryos. In recent years, clinical studies have found that it is helpful to the natural pregnancy of patients with EM after operation, and is beneficial to improve pain symptoms and reduce the recurrence rate. Basic studies have also confirmed the inhibitory effect of didroxyprogesterone on em. However, the existing studies with small sample size are not enough to draw a convincing conclusion that didroxyprogesterone promotes the pregnancy rate after em, and there is a lack of Chinese data. This study intends to use a multicenter, prospective, open, randomized controlled clinical trial design to explore the value of didroxyprogesterone in the treatment of EM related infertility patients, so as to provide direct evidence for improving the postoperative natural pregnancy rate of EM patients.

Conditions

• Pregnancy Rate

Interventions

DRUG

didroxyprogesterone

Didroxyprogesterone group: the first menstrual cycle after operation began on the 14th to 27th day of each menstrual cycle. Didroxyprogesterone 10mg bid was given orally. It was planned to use 6 menstrual cycles (if the patient was naturally pregnant during the medication, the drug could be stopped), and guide the patient to try pregnancy. The observation period was 12 menstrual cycles after operation. Control group: no drugs were used after operation, and the patients were guided to try pregnancy. The observation period was 12 menstrual cycles after operation. Subjects need to complete up to 6 follow-up visits, including the first month after operation, the first menstrual cycle d7-13 after operation, the fourth menstrual cycle d7-13 after operation, the seventh menstrual cycle d7-13 after operation, the 13th menstrual cycle d7-13 after operation and 1-2 months after termination of pregnancy

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-10

Primary Completion

2025-01-10

Completion

2025-12-10