SO+IUI After Operative Laparoscopy in Patients With Advanced Stage Endometriosis

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Sodium Citrate; Zuclomiphene

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.