Study Stopped
no women were recruited
Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles
Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Started Jan 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedNovember 30, 2022
November 1, 2022
Same day
December 7, 2019
November 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Total gonadotrophins dose
14 days
Secondary Outcomes (2)
Duration of ovarian stimulation
14 days
Endometrial thickness
14 days
Study Arms (2)
Soft ovarian stimulation protocol
OTHERconventional ovarian stimulation protocol
OTHERInterventions
150 IU of highly purified menotropins intramuscular
recombinant Follicular stimulating hormone 300- 400 IU
Eligibility Criteria
You may qualify if:
- Advanced maternal age (≥40 years) .
- Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).
- An abnormal ovarian reserve tests
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women Health Hospital - Assiut university
Asyut, 71111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
December 7, 2019
First Posted
December 10, 2019
Study Start
January 1, 2021
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
November 30, 2022
Record last verified: 2022-11