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Clinical Trials/EUCTR2016-001590-32-ES
EUCTR2016-001590-32-ES
Active, not recruiting
Phase 1

Comparison of two protocols of controlled ovarian stimulation with highly purified menotropin in low-responder patients according to Bologna criteria treated in Spanish public hospitals.

Manuel Macía Cortiñas0 sites64 target enrollmentFebruary 8, 2018
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DrugsMENOPURTESTOSTERONA TRANSDÉRMICA GELTRIPTORELINE ACETATEORAL CONTRACEPTIVESPROGESTERONE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Manuel Macía Cortiñas
Enrollment
64
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 8, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Manuel Macía Cortiñas

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who initiate COS therapy with GnRH agonist and ICSI.
  • •2\. Age \<40 years with primary infertiliy including tubal factor.
  • •3\. Patients with low ovarian reserve (must meet at least two of the three Bologna criteria: RFA \<7 in both ovaries, AMH \<0\.5\-1\.1 ng/dL and low response to stimulation in a previous cycle, defined as recovery of \<4 oocytes or canceled cycle).
  • •4\. Normal or mild male factor (SMR\=3 millions, normal morphology 4%).
  • •5\. BMI \<30 kg/m2\.
  • •6\. Presence of normal ovulatory cycles (every 26\-35 days).
  • •7\. Patients who sign informed consent.
  • •8\. Presence of both ovaries.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\. Endometriosis or uterine malformation
  • •2\. PCOS according to Rotterdam criteria
  • •3\. Presence of hydrosalping
  • •4\. Intolerance or allergy to drugs
  • •5\. Moderate or severe male factor

Outcomes

Primary Outcomes

Not specified

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