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

NCT02520505 | Withdrawn

• 1 other identifier: 15-149
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy rates in SO+IUI versus expectant management

  The primary objective of this study is to determine whether or not immediate clomiphene citrate SO+IUI is more efficacious for improving pregnancy rates in patients with stage III/IV endometriosis after operative laparoscopy as compared expectant management.

  Patients will participate in the study up to 6 months, starting from the first menstrual period after surgery until the completion of the second three month arm of the study.

Secondary Outcomes (4)

• Post-operative fecundity rates in SO+IUI versus expectant management groups

  Patients will participate in the study up to 6 months, starting from the first menstrual period after surgery until the completion of the second three month arm of the study.

• Patient characteristics in SO+IUI versus expectant management groups

  Patients will participate in the study up to 6 months, starting from the first menstrual period after surgery until the completion of the second three month arm of the study.

• Time to pregnancy in SO+IUI versus expectant management groups

  Patients will participate in the study up to 6 months, starting from the first menstrual period after surgery until the completion of the second three month arm of the study.

• Endometriosis fertility index in SO+IUI versus expectant management groups

  Patients will participate in the study up to 6 months, starting from the first menstrual period after surgery until the completion of the second three month arm of the study.

Study Arms (2)

Expectant Management: Timed Intercourse

OTHER

Patients randomized to expectant management will be counseled on timed intercourse and the window in which intercourse should be performed during the randomization phone call. Patients will be encouraged to contact their fertility doctor and the primary investigator if they become pregnant and an estimated date of confinement will be calculated based upon the patient's last menstrual period. Patients will also be notified that they will be contacted at the end of the six month timeframe to inquire as to whether or not they became pregnant.

Behavioral: Timed intercourse

Supraovulation + IUI

ACTIVE COMPARATOR

Women randomized to super ovulation (SO) will be treated according to a standard protocol under the care of their staff physician and fertility nurses. The patient will be treated with 100mg/day of clomiphene citrate starting on day 3 of the menstrual cycle and ending on day 7. Intrauterine insemination will be performed 36 hours after the hCG surge (follicle rupture) by inserting a catheter through the cervix of the patient in dorsal lithotomy position.

Drug: Supraovulation clomiphene citrate; Procedure: Intrauterine Insemination

Interventions

Supraovulation clomiphene citrate DRUG

Treatment with clomiphene citrate during day 3 to 7 of the menstrual cycle.

Also known as: Clomiphene citrate

Supraovulation + IUI

Timed intercourse BEHAVIORAL

Timing intercourse during the fertile window in the menstrual cycle. Patients may also utilize an ovulation predictor kit to determine time of ovulation.

Also known as: Expectant management

Expectant Management: Timed Intercourse

Intrauterine Insemination PROCEDURE

Intrauterine insemination will be performed \~36 hours after the time the woman ovulates, as determined by an ovulation predictor kit.

Also known as: IUI

Supraovulation + IUI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Endometriosis; Infertility

Interventions

Clomiphene; Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Lisa C Hickman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2015
• First Posted: August 13, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

US (1)