SO+IUI After Operative Laparoscopy in Patients With Advanced Stage Endometriosis
Withdrawn before enrolling · Not applicable
Conditions studied: Endometriosis, Infertility
In brief
This is a prospective randomized control, crossover trial to determine if supraovulation with clomiphene citrate and intrauterine insemination is more efficacious than expectant management in women with stage III or IV endometriosis who have recently undergone operative laparoscopy.
Key facts
- Study ID
- NCT02520505
- Run by
- The Cleveland Clinic
- People needed
- 0
- Starts
- 2015-04-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-01-24
Who can join
Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Using the ASRM classification criteria, all patients included will have a diagnosis of stage III or IV endometriosis from a surgery performed within the Cleveland Clinic Foundation.
- Patients who present with idiopathic infertility who are found to have advanced stage endometriosis on diagnostic laparoscopy will be included as long as ablation and/or excision was performed on all visible endometriosis and adhesions.
- All patients must have at least one patent fallopian tube, assessed by hysterosalpingogram, hysteroscopy, or at the time of laparoscopy via chromopertubation.
- Patients with additional conditions affecting fertility will be included given the factors are classified as mild. This includes uterine leiomyoma(s) with a normal uterine cavity, polycystic ovarian syndrome, and mild male factor infertility (<15 million but >10 million motile sperm per ejaculate before washing).
You may not qualify if…
- Exclusion criteria include patients with additional causes for infertility such as male factor (<15 million motile sperm per ejaculate), ovulatory dysfunction, polycystic ovarian syndrome, age >35 years, and septate uterus.
- Patients who have had hormonal therapy in the three months prior to surgery will also be excluded, as this can impact the staging of disease.
- Patients will also be excluded from the study if they have previously undergone treatments for infertility, such as ovulation induction, IUI and/or IVF.
Where it is running
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.