Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI

NCT ID: NCT02741154

Last Updated: 2017-09-06

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

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-12

Study Completion Date

2017-09-03

Brief Summary

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study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI

Detailed Description

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This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .

Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol

Conditions

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Infertility Indicated for ICSI

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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aromataze group

patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection

Group Type EXPERIMENTAL

induction with aromataze inhibitor

Intervention Type DRUG

letrozole 2.5mg once daily start in the first day of menses for 5days

HMG

Intervention Type DRUG

HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter

GnRh a

Intervention Type DRUG

antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection

HCG

Intervention Type DRUG

10.000 IU HCG injection when at least three follicles reach 17mm in diameter

classic group

same protocol for induction without aromataze inhibitor

Group Type ACTIVE_COMPARATOR

HMG

Intervention Type DRUG

HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter

GnRh a

Intervention Type DRUG

antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection

HCG

Intervention Type DRUG

10.000 IU HCG injection when at least three follicles reach 17mm in diameter

Interventions

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induction with aromataze inhibitor

letrozole 2.5mg once daily start in the first day of menses for 5days

Intervention Type DRUG

HMG

HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter

Intervention Type DRUG

GnRh a

antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection

Intervention Type DRUG

HCG

10.000 IU HCG injection when at least three follicles reach 17mm in diameter

Intervention Type DRUG

Other Intervention Names

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letrozole merional decapeptyl choriomon

Eligibility Criteria

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Inclusion Criteria

* infertlity indicated for ICSI
* Ovarian factor
* Tubal factor
* Unexplained infertility
* poor responders

Exclusion Criteria

* Expected high responder
* Endometriosis
* Male and uterine factors
* Ovarian mass or cyst
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Reham Elkhateeb

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

References

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Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0.

Reference Type RESULT
PMID: 11937133 (View on PubMed)

Other Identifiers

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MUH20167

Identifier Type: REGISTRY

Identifier Source: secondary_id

MUH 20167

Identifier Type: -

Identifier Source: org_study_id

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