Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis

NCT ID: NCT01334762

Last Updated: 2011-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Letrozole/IUI

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.

Group Type EXPERIMENTAL

Letrozole/IUI

Intervention Type DRUG

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.

CC/IUI

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.

Group Type ACTIVE_COMPARATOR

CC/IUI

Intervention Type DRUG

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.

Interventions

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Letrozole/IUI

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.

Intervention Type DRUG

CC/IUI

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mansoura Faculty of Medicine, Mansoura University.

Principal Investigators

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Hatem Abu Hashim, MD MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Mohamed El Rakhawy, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Ibrahim Abd Elaal

Role: STUDY_DIRECTOR

Mansoura University Hospital

Locations

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Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 12372451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16952506 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22181973 (View on PubMed)

Other Identifiers

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FMH-92-B

Identifier Type: -

Identifier Source: secondary_id

MU-157x

Identifier Type: -

Identifier Source: org_study_id

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