Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

NCT ID: NCT04193930

Last Updated: 2022-11-30

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-01-01

Brief Summary

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During assisted reproduction technology treatments like in vitro fertilization, some patients give a poor ovarian response to controlled ovarian hyperstimulation. The European Society of Human Reproduction and Embryology consensus defined poor response to ovarian stimulation during in vitro fertilization with Bologna criteria.

Bologna criteria: At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years). (ii) Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).

(iii) An abnormal ovarian reserve test Most controlled ovarian hyperstimulation regimens currently used for expected poor responders are based on using a high daily dose (300- 450 IU/day) of exogenous gonadotropins. Giving a high gonadotropin dose obviously increases the cost of in vitro fertilization, a consequence that would be acceptable if paralleled by an improvement in in vitro fertilization outcome. Unfortunately, however, the available data suggest that increasing the daily gonadotropins dose may increase the number of retrieved oocytes, but not the final success rate of in vitro fertilization.

Detailed Description

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Conditions

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ART

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soft ovarian stimulation protocol

Group Type OTHER

Letrozole

Intervention Type DRUG

Oral tablet letrozole 2,5 mg/twice daily for 5 days

Menotropins

Intervention Type DRUG

150 IU of highly purified menotropins intramuscular

conventional ovarian stimulation protocol

Group Type OTHER

Menotropins

Intervention Type DRUG

150 IU of highly purified menotropins intramuscular

recombinant Follicular stimulating hormone

Intervention Type DRUG

recombinant Follicular stimulating hormone 300- 400 IU

Interventions

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Letrozole

Oral tablet letrozole 2,5 mg/twice daily for 5 days

Intervention Type DRUG

Menotropins

150 IU of highly purified menotropins intramuscular

Intervention Type DRUG

recombinant Follicular stimulating hormone

recombinant Follicular stimulating hormone 300- 400 IU

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced maternal age (≥40 years) .
* Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).
* An abnormal ovarian reserve tests

Exclusion Criteria

* Hyper or Normal responders patients.
* Endocrine or metabolic diseases like hyperprolactinoma, hypothyroidism,...etc
* Patients with a severe male factor abnormality. 4-Patients with systemic disease such as chronic renal disease, chronic liver disease, etc
Minimum Eligible Age

40 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ICSI_PR

Identifier Type: -

Identifier Source: org_study_id

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