NCT01334762

Brief Summary

To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

3.1 years

First QC Date

April 11, 2011

Last Update Submit

April 12, 2011

Conditions

Endometriosis

Keywords

minimal to mild endometriosisletrozoleclomiphene citrateIUI

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate per cycle

    6-7 weeks gestation

Secondary Outcomes (1)

  • Miscarriage rate.

    Up to 20 weeks gestation

Study Arms (2)

Letrozole/IUI

EXPERIMENTAL

Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

Drug: Letrozole/IUI

CC/IUI

ACTIVE COMPARATOR

Patients received 100 mg CC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

Drug: CC/IUI

Interventions

Letrozole/IUIDRUG

Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

Letrozole/IUI
CC/IUIDRUG

Patients received 100 mg lCC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

CC/IUI

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
  • No other infertility factors.
  • Normal serum basal hormone levels as well as documented ovulation

You may not qualify if:

  • Moderate or severe endometriosis
  • Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
  • Age more than 36 years, BMI more than 30 kg/m2
  • women with a previous pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (3)

  • Dmowski WP, Pry M, Ding J, Rana N. Cycle-specific and cumulative fecundity in patients with endometriosis who are undergoing controlled ovarian hyperstimulation-intrauterine insemination or in vitro fertilization-embryo transfer. Fertil Steril. 2002 Oct;78(4):750-6. doi: 10.1016/s0015-0282(02)03343-5.

    PMID: 12372451BACKGROUND

  • Werbrouck E, Spiessens C, Meuleman C, D'Hooghe T. No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination. Fertil Steril. 2006 Sep;86(3):566-71. doi: 10.1016/j.fertnstert.2006.01.044.

    PMID: 16952506BACKGROUND

  • Abu Hashim H, El Rakhawy M, Abd Elaal I. Randomized comparison of superovulation with letrozole vs. clomiphene citrate in an IUI program for women with recently surgically treated minimal to mild endometriosis. Acta Obstet Gynecol Scand. 2012 Mar;91(3):338-45. doi: 10.1111/j.1600-0412.2011.01346.x. Epub 2012 Jan 26.

    PMID: 22181973DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Hatem Abu Hashim, MD MRCOG

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

  • Mohamed El Rakhawy, MD

    Mansoura University Hospital

    STUDY CHAIR

  • Ibrahim Abd Elaal

    Mansoura University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

May 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations

EG(1)