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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04193930
Enrollment
0
Registered
2019-12-10
Start date
2021-01-01
Completion date
2021-01-01
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART

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.

Interventions

DRUGLetrozole

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

150 IU of highly purified menotropins intramuscular

DRUGrecombinant Follicular stimulating hormone

recombinant Follicular stimulating hormone 300- 400 IU

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Total gonadotrophins dose14 days

Secondary

MeasureTime frameDescription
Duration of ovarian stimulation14 days
Endometrial thickness14 daysby ultrasounds

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026