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Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle

NCT ID: NCT01006954

Last Updated: 2018-12-19

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

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-02-28

Brief Summary

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About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.

Detailed Description

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In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.

The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.

Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become \>14.

2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Conditions

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Infertility

Keywords

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Poor responder Flare up Micro dose GnRH agonist flare up IVF/ICSI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Flare Up

Flare up protocol in poor responders for IVF/ICSI

Group Type ACTIVE_COMPARATOR

Flare up

Intervention Type DRUG

Flare up protocol in poor responders for IVF/ICSI

Microdose GnRh

Microflare protocol in poor responders for IVF/ICSI

Group Type EXPERIMENTAL

Microdose GnRh

Intervention Type DRUG

Microflare protocol in poor responders for IVF/ICSI

Interventions

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Microdose GnRh

Microflare protocol in poor responders for IVF/ICSI

Intervention Type DRUG

Flare up

Flare up protocol in poor responders for IVF/ICSI

Intervention Type DRUG

Other Intervention Names

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Case Standard treatment

Eligibility Criteria

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Inclusion Criteria

Poor responders (Presence of at least two of following items is necessary for inclusion to the study)

* History of Cycle Cancellation
* History of oocyte number 3 (in previous cycle)
* History of Number of antral follicle \< 5 in previous cycle
* Age≥38
* FSH\>12 on day 2 or 3
* Ovarian Volume 3 cm3

Exclusion Criteria

* Male factor (azospermi)
* Myoma ≥6cm
* One way ovary
* Tumor or cyst \>13mm
* Age \>42
Minimum Eligible Age

30 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tahereh Madani, MD

Role: STUDY_CHAIR

Royan Institute

Firoozeh Ghaffari, MD

Role: STUDY_DIRECTOR

Royan Institute

Tahereh Madani, MD

Role: PRINCIPAL_INVESTIGATOR

Royan Institute

Locations

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1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR

Tehran, , Iran

Site Status

Countries

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Iran

References

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Ghaffari F, Jahangiri N, Madani T, Khodabakhshi S, Chehrazi M. Randomized controlled trial of gonadotropin-releasing hormone agonist microdose flare-up versus flare-up among poor responders undergoing intracytoplasmic sperm injection. Int J Gynaecol Obstet. 2020 Jan;148(1):59-64. doi: 10.1002/ijgo.12988. Epub 2019 Oct 18.

Reference Type DERIVED
PMID: 31569274 (View on PubMed)

Related Links

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http://WWW.Royaninstitute.org

Related Info

Other Identifiers

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Royan-Emb-003

Identifier Type: -

Identifier Source: org_study_id