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Levofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets in Chronic Endometritis

ConditionIVF
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-42
SponsorPeking University Third Hospital

About this trial

This is a single randomised controlled trial. The investigators plan to randomise 800 participants to the levofloxacin plus metronidazole suppositories versus levofloxacin co-administered with metronidazole tablets for the treatment of chronic endometritis in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infertile patients aged 20-42 years

Hysteroscopy and endometrial biopsy were performed, and the

Pathological diagnosis was chronic endometritis

Serum FSH level on the second day of menstruation was ≤12U/L

Disqualifiers

Patients with the following diagnoses: submucosal myoma; Uterine malformation or previous surgery for correction of uterine deformity; Intrauterine adhesions; The previous history of pelvic tuberculosis or endometrial tuberculosis or the current pathology suggested endometrial tuberculosis; Endometrial hyperplasia or endometrial cancer

Patients with spouse, previous fetal or child chromosomal abnormalities who plan to undergo preimplantation genetic screening

Patients with a history of allergy to study drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levofloxacin Plus Metronidazole Suppositories

    Drug

    Administer a two-week course of Levofloxacin Plus Metronidazole Suppositories to patients diagnosed with chronic endometritis.

  • Levofloxacin co-administered with Metronidazole tablets

    Biological/Vaccine

    Administer a two-week course of Levofloxacin in combination with Metronidazole tablets to patients diagnosed with chronic endometritis.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Levofloxacin Plus Metronidazole Suppositories groupExperimental treatment 1 intervention
Group B: Levofloxacin co-administered with Metronidazole tablets groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

live birth rate after the first embryo transfer

Live birth is defined as the delivery of at least one baby after 22 weeks of gestation Oversight that exhibits any sign of life.

Time frame
22 weeks to 43 weeks gestation after the first embryo transfer cycle

Secondary outcomes

1

Clinical pregnancy

It is defined as at least one gestational sac on ultrasound at around 7 weeks'gestation with the detection of heart-beat activity,

Time frame
around 7 weeks' gestation after the first embryo transfer cycle
2

Ongoing pregnancy

definedIs pregnancy with detectable heart rate at 12 weeks' gestation or beyond

Time frame
12 weeks to 43weeks gestation after the first embryo transfer cycle
3

Biochemical pregnancy

defined as a positive pregnancy test

Time frame
about 14 days after embryo transfer
4

Miscarriage

defined as spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable or is/are absorbed or expelled from the uterus.

Time frame
6-22 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: