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Clinical Trials/EUCTR2018-003556-20-PT
EUCTR2018-003556-20-PT
Active, not recruiting
Phase 1

How do different ovarian stimulation protocols affect endometrial receptivity during a fresh in vitro fertilization attempt? - RESET (Receptivity Enhancement through Effective Stimulation prior to Transfer) trial

INSTITUTO VALENCIANO DE INFERTILIDADE - CLÍNICA DE REPRODUÇÃO ASSISTIDA, LDA0 sites24 target enrollmentApril 30, 2019
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DrugsElonvaPuregon

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
INSTITUTO VALENCIANO DE INFERTILIDADE - CLÍNICA DE REPRODUÇÃO ASSISTIDA, LDA
Enrollment
24
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 30, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Informed consent form (ICF) dated and signed.
  • •2\. Age: \=18 and \<40 years old.
  • •3\. Antral follicular count (AFC): \=5 and \<20\.
  • •4\. Anti\-Müllerian Hormone (AMH): \=1\.1 ng/mL and \<2\.5 ng/mL, performed in the 12 months prior to inclusion.
  • •5\. Body Mass Index (BMI): \=18\.5 Kg/m2 and \<30 Kg/m2\.
  • •6\. Weight: \=50 kg and \<80 kg.
  • •7\. First or second Assisted Reproductive Technologies (ART) cycle or fertility preservation cycle.
  • •8\. Regular menstrual cycles (between 22 and 35 days).
  • •9\. Two ovaries present.
  • •10\. Pregnancy\-wish.

Exclusion Criteria

  • •1\. Simultaneous participation in another clinical study.
  • •2\. Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of OS (\=300 IU/day) or Ovarian hyperstimulation syndrome (OHSS), regardless of gonadotropin dose.
  • •3\. Known reasons for impaired implantation (specifically hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis).
  • •4\. Repeated miscarriages (\>2 previous biochemical pregnancies or \>2 spontaneous miscarriages).
  • •5\. Recurrent implantation failure (\>3 failed cycles with good quality embryos).
  • •6\. Polycystic ovary syndrome (PCOS).
  • •7\. Tumours of the ovary, breast, uterus, pituitary or hypothalamus.
  • •8\. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
  • •9\. Ovarian cysts or enlarged ovaries.
  • •10\. Fibroid tumours of the uterus incompatible with pregnancy.

Outcomes

Primary Outcomes

Not specified

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