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Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

A

Assiut University

Status

Withdrawn

Conditions

ART

Treatments

Drug: Letrozole
Drug: recombinant Follicular stimulating hormone
Drug: Menotropins

Study type

Interventional

Funder types

Other

Identifiers

NCT04193930
ICSI_PR

Details and patient eligibility

About

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.

Sex

Female

Ages

40 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Soft ovarian stimulation protocol
Other group
Treatment:
Drug: Menotropins
Drug: Letrozole
conventional ovarian stimulation protocol
Other group
Treatment:
Drug: recombinant Follicular stimulating hormone
Drug: Menotropins

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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