Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

Not Applicable

Withdrawn

• Conditions: ART
• Interventions: Drug: Menotropins; Drug: Letrozole; Drug: recombinant Follicular stimulating hormone

• Registration Number: NCT04193930
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-07
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-10
• Study Start: 2021-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-26
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional ovarian stimulation protocol	Menotropins	-
conventional ovarian stimulation protocol	recombinant Follicular stimulating hormone	-
Soft ovarian stimulation protocol	Letrozole	-
Soft ovarian stimulation protocol	Menotropins	-

Primary Outcome Measures

Name	Time	Method
Total gonadotrophins dose	14 days

Secondary Outcome Measures

Name	Time	Method
Duration of ovarian stimulation	14 days
Endometrial thickness	14 days	by ultrasounds

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt