Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04193930
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ART	Drug: Letrozole; Drug: Menotropins; Drug: recombinant Follicular stimulating hormone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Soft ovarian stimulation protocol	Drug: Letrozole; Oral tablet letrozole 2,5 mg/twice daily for 5 days; Drug: Menotropins; 150 IU of highly purified menotropins intramuscular
Other: conventional ovarian stimulation protocol	Drug: Menotropins; 150 IU of highly purified menotropins intramuscular; Drug: recombinant Follicular stimulating hormone; recombinant Follicular stimulating hormone 300- 400 IU

Outcome Measures

Primary Outcome Measures

1. Total gonadotrophins dose [14 days]

Secondary Outcome Measures

1. Duration of ovarian stimulation [14 days]

2. Endometrial thickness [14 days]

   by ultrasounds

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital - Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04193930
• Other Study ID Numbers: ICSI_PR
• First Posted: Dec 10, 2019
• Last Update Posted: Dec 10, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Letrozole; Menotropins; Hormones; Follicle Stimulating Hormone

Study Results

No Results Posted as of Dec 10, 2019