Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

ART Clinical Trial

Official title:

Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04193930
• Other study ID #: ICSI_PR
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• ART

Intervention

Drug:
• Letrozole
Oral tablet letrozole 2,5 mg/twice daily for 5 days
• Menotropins
150 IU of highly purified menotropins intramuscular
• recombinant Follicular stimulating hormone
recombinant Follicular stimulating hormone 300- 400 IU

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total gonadotrophins dose		14 days
Secondary	Duration of ovarian stimulation		14 days
Secondary	Endometrial thickness	by ultrasounds	14 days